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58664 Ankle support with belt polyester material-M
EUDAMEDClass I (EU MDR)
Ref 58664Ref 58664 BOX
Identity
- Trade Name
- 58664 Ankle support with belt polyester material-M EUDAMED
- Device Name
- SUPPORT EUDAMED
- Model / Reference
- 58664 EUDAMED58664 BOX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864859104 EUDAMED06973864858664 EUDAMED
- Basic UDI-DI
- 697386485DEPANSUPPORT8V EUDAMED
- Direct Marketing DI
- 06973864859104 EUDAMED06973864858664 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
58664 Ankle support with belt polyester material-M by Suzhou Sunmed Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED f772caf6-c77f-4299-a93c-57f940c3489e 61 fields · synced Jul 9, 2026
- EUDAMED 024b8532-27b2-49a4-b6a0-8e8643d570d7 61 fields · synced May 18, 2026