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Conwell
EUDAMEDClass I (EU MDR)
Ref 5309 ROM Elbow Brace (S/M)Model 5301, 53020, 53030, 5304, 5305, 53070, 5308, 5309, 53100, 53110, 53120, 5313, 5314, 5315, 53160, 5319, 53200, 53210, 53220, 5325, 5326, 53270, 53280, 5329, 53300, 53350, 53400, 5345
Identity
- Trade Name
- Conwell EUDAMED
- Device Name
- Soft Support, Brace, Orthosis (Wrist series) EUDAMED
- Model / Reference
- 5301, 53020, 53030, 5304, 5305, 53070, 5308, 5309, 53100, 53110, 53120, 5313, 5314, 5315, 53160, 5319, 53200, 53210, 53220, 5325, 5326, 53270, 53280, 5329, 53300, 53350, 53400, 5345 EUDAMED5309 ROM Elbow Brace (S/M) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878932271 EUDAMED
- Basic UDI-DI
- 471987893WRIST-53000W6 EUDAMED
- EMDN Code
- Y060603,Y060609,Y060612,Y060615 EUDAMED
Classification
- Device Class
- Class I 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
Conwell by Conwell Medical Co., Ltd. — Class I — CE/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 | 471987893WRIST-53000W6 | Class I | Active |
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Manufacturer
- Manufacturer
- Conwell Medical Co., Ltd.
- EUDAMED SRN
- TW-MF-000012101
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d2d506e0-1ab3-42a4-87ea-14a86152654d 61 fields · synced Oct 6, 2026