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58442 Elbow support with belt polyester material-S
EUDAMEDClass I (EU MDR)
Ref 58442
Identity
- Trade Name
- 58442 Elbow support with belt polyester material-S EUDAMED
- Device Name
- SUPPORT EUDAMED
- Model / Reference
- 58442 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864853744 EUDAMED
- Basic UDI-DI
- 697386485DEPANSUPPORT8V EUDAMED
- Direct Marketing DI
- 06973864853744 EUDAMED
- EMDN Code
- Y060630 SHOULDER-ELBOW-WRIST- HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
58442 Elbow support with belt polyester material-S 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 b5150ea1-bdca-4c1a-8d61-59f79a242208 61 fields · synced Oct 6, 2026