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58435 Wrist support with belt polyeter material-XL
EUDAMEDClass I (EU MDR)
Ref 58435 BOX
Identity
- Trade Name
- 58435 Wrist support with belt polyeter material-XL EUDAMED
- Device Name
- SUPPORT EUDAMED
- Model / Reference
- 58435 BOX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864858435 EUDAMED
- Basic UDI-DI
- 697386485DEPANSUPPORT8V EUDAMED
- Direct Marketing DI
- 06973864858435 EUDAMED
- EMDN Code
- Y060630 SHOULDER-ELBOW-WRIST- HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
58435 Wrist support with belt polyeter material-XL by Suzhou Sunmed 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 | 697386485DEPANSUPPORT8V | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3bb8722d-7f1a-4fad-bcf1-144b322a9f91 61 fields · synced Oct 6, 2026