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cushion
EUDAMEDClass I (EU MDR)
Ref SH2162A113Model SH2162、SH5132、SH3132、SC1111
Identity
- Device Name
- cushion EUDAMED
- Model / Reference
- SH2162、SH5132、SH3132、SC1111 EUDAMEDSH2162A113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850082804078 EUDAMED
- Basic UDI-DI
- 0850082804A0001DJ EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
cushion by Changsha Anxiang Medical Technology Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850082804A0001DJ | Class I | Active |
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Manufacturer
- Manufacturer
- Changsha Anxiang Medical Technology Co., LTD
- EUDAMED SRN
- CN-MF-000045942
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 821cfb10-f9f3-4179-be2b-8bb7b4e1a564 61 fields · synced Jun 19, 2026