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Conwell
EUDAMEDClass I (EU MDR)
Ref 5103 Plastic Adjustable Collar (M) Model 5101, 5102, 5103, 5104, 5106, 5107, 5108, 5109, 51100
Identity
- Trade Name
- Conwell EUDAMED
- Device Name
- Soft Support, Brace, Orthosis (Collar series) EUDAMED
- Model / Reference
- 5101, 5102, 5103, 5104, 5106, 5107, 5108, 5109, 51100 EUDAMED5103 Plastic Adjustable Collar (M) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878931342 EUDAMED
- Basic UDI-DI
- 471987893COLLAR-51000Y5 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 — 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 | 471987893COLLAR-51000Y5 | 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 7f1380f5-3a48-486c-86e9-034f5e3d05d8 61 fields · synced May 23, 2026