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Conwell
EUDAMEDClass I (EU MDR)
Ref 5914 Night Splint (L)Model 5901, 5902, 5904, 5905, 5906, 5907, 5908, 5909, 5912, 5913, 5914, 5917, 59180, 59190, 59200, 5921, 5922, 5923, 5924, 5925, 5926, 5927, 5930, 5931, 5932, 5933, 5934, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 6101, 6201
Identity
- Trade Name
- Conwell EUDAMED
- Device Name
- Soft Support, Brace, Orthosis (Ankle series & Foot products) EUDAMED
- Model / Reference
- 5901, 5902, 5904, 5905, 5906, 5907, 5908, 5909, 5912, 5913, 5914, 5917, 59180, 59190, 59200, 5921, 5922, 5923, 5924, 5925, 5926, 5927, 5930, 5931, 5932, 5933, 5934, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 6101, 6201 EUDAMED5914 Night Splint (L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878936101 EUDAMED
- Basic UDI-DI
- 471987893ANKLE-59000TR EUDAMED
- EMDN Code
- Y061203,Y06120601 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 | 471987893ANKLE-59000TR | 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 be15978c-aecf-4d82-841f-eca606fe509e 61 fields · synced May 23, 2026