The first page of each certificate and quality document held by the factory behind SkelundTech, with who issued it, what it covers and which model samples it names. Select a page to enlarge it. Copies are shared on request for your model and destination. None of these documents is a medical-device approval, and we make no medical claims.
Certificates and test reports
Quality system, CE directives and the pressure-vessel type test.
Five issued documents, plus the ASME U certification service that is under way.
ISO 13485:2016
Certificate
ISO 13485:2016 quality management system certificate
Issued 13 March 2026 · valid until 12 March 2029, subject to surveillance audits
Holder
Zhejiang Oxygen Yi Medical Equipment Co., Ltd — the factory entity behind SkelundTech
Scope
Design, production and sales of commercial hyperbaric oxygen chambers (portable and rigid hyperbaric oxygen chambers)
Certifies the factory's quality management system. It is not an approval of any individual product. Bilingual certificate — English page shown; the Chinese page is the second image.
ISO 13485:2016 — Chinese page
CE · EMC
Certificate
Certificate of Conformity — EMC Directive 2014/30/EU
Directive
Electromagnetic compatibility, 2014/30/EU
Standards
EN IEC 55014-1:2021 · EN IEC 55014-2:2021 · EN IEC 61000-3-2:2019/A1:2021 · EN 61000-3-3:2013+A2:2021
Issued by
Shenzhen ZCT Technology Co., Ltd., 30 October 2024
Certificate No.
24ZCTB1025001SC · test report 24ZCTB1025001SP
Product
Hyperbaric oxygen chamber — factory model codes EMS05 (2.0 ATA) and the soft-chamber codes listed on the certificate
Based on the evaluation of one sample of the listed models; it does not assess ongoing production. CE marking applies only where all relevant European directives are met.
CE · LVD
Certificate
Certificate of Conformity — Low Voltage Directive 2014/35/EU
Directive
Low voltage (electrical safety), 2014/35/EU
Standards
EN 60335-1:2012 + AC:2014 + A11:2014 + A13:2017 + A1:2019 + A14:2019 + A2:2019 · EN 62233:2008
Issued by
Shenzhen ZCT Technology Co., Ltd., 30 November 2024
Certificate No.
24ZCTB1025002SC · test report 24ZCTB1025002SP
Product
Hyperbaric oxygen chamber — factory model codes EMS05 (2.0 ATA) and the soft-chamber codes listed on the certificate
Based on the evaluation of one sample of the listed models; it does not assess ongoing production.
RoHS
Certificate
Verification of Conformity — RoHS Directive 2011/65/EU and (EU) 2015/863
Directive
Restriction of hazardous substances, 2011/65/EU as amended by (EU) 2015/863
Standard
IEC 62321:2013
Issued by
Shenzhen ZCT Technology Co., Ltd., 30 October 2024
Certificate No.
24ZCTB1025003SC · test report 24ZCTB1025003SP
Product
Hyperbaric oxygen chamber — factory model codes EMS05 (2.0 ATA) and the soft-chamber codes listed on the certificate
Result: conform. Covers the ten restricted substances listed in the directive for the tested sample.
EN 286-1 type test
Test report
Type test report — EN 286-1 and EN 10207 (simple unfired pressure vessels)
Standards
EN 286-1:1998 + AC:2002 + A1:2002 + A2:2005 · EN 10207:2017
Issued by
Shenzhen CTG Testing Co., Ltd., 25 September 2025
Report No.
CTG2509250922E_SR693AB (66 pages — first page shown)
Test item
Hard-shell oxygen chamber, factory model YT03 (additional model M8); samples received 17 September 2025, tested 17–25 September 2025
A type test of the listed model samples. The applicable welding-related requirements — welded attachments and supports, consumables, joint design, shell connections, welder and procedure qualification and weld inspection — are recorded as Pass. The full report is shared on request.
ASME U · in progress
In progress · service agreement
ASME U Designator & Certificate — certification service agreement (in progress)
Document
Contract for ASME U Designators & Certificate Service — SGS-CSTC Standards Technical Services, Industries Service
Reference
NBINIPC260015Q Rev.0
Signed
14 August 2026
Applicant
Zhejiang Yangyi Medical Equipment Co., Ltd. (浙江氧怡医疗器械有限公司) — the factory entity behind SkelundTech
Status
Certification service under way — not an issued ASME authorization
First page of the service contract shown. No ASME marking is claimed for any chamber until the certificate is issued; it will be published here when it is.
Process documents
How the chamber body is welded and tested.
Our own documented welding process for the hard-shell body and the segmented designs.
Welding work instruction
Process document
Chamber welding work instruction
Document No.
A1002 / A-B-1002, prepared 15 March 2025
Materials
304 stainless steel · Q235 carbon steel
Welding
Argon arc welding · CO2-shielded arc welding
Steps
Bevel the joint edges, weld inside and outside, join the rail support plate, base and exterior trim, join the complete assembly, then pressure-test for leaks
Our own documented process for the hard-shell chamber body: how the shell sections are prepared, welded and tested before fit-out.
Segmented welding drawing
Process drawing
Segmented chamber body — welding process drawing
Document
A3 engineering drawing (Chinese annotations) by the factory
Content
Where each flange section is positioned and tack-welded, then fully welded on both sides and ground after welding
The drawing behind the segmented chamber designs — LUMEN's flanged side modules and the HORIZON concept.
How to read them
Scope first, badges last.
A certificate names a company, a standard and the model samples tested — coverage is tied to what it lists.
The ISO 13485 certificate covers the factory's quality management system, not individual chambers.
The CE conformity documents and the EN 286-1 type test are based on tested samples of the listed factory model codes.
The ASME U entry is a signed certification service agreement — the certificate itself is not issued yet, and no ASME marking is claimed until it is.
Tell us your model and destination and we send the documents that apply, with the full test reports.
