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SIMPLE Thumb brace W4
EUDAMEDClass I (EU MDR)
Ref 31904-MModel 31003,31004,31020,31302,30303,31501,31502,31801,31804,31805,31806,31807,31808,31809,31901,31906,30903,30904,41003,41004,41011,41012,41301,31001,31002,31010,31011,31012,31013,31014,31015,31017,31018,31019,31020,41009,42001,42003,42004,52301
Identity
- Trade Name
- SIMPLE Thumb brace W4 EUDAMED
- Device Name
- SIMPLE Shoulder Abduction Immobilizer E6, CryoTreat Shoulder, SIMPLE Arm Sling E3, SIMPLE Multi-functional Arm Sling E4, SIMPLE Shoulder Brace E8, SIMPLE Arm Sling Shoulder Brace E5,SIMPLE Arm Sling Shoulder Brace E16,SIMPLE Arm Sling Shoulder Brace E17 EUDAMED
- Model / Reference
- 31003,31004,31020,31302,30303,31501,31502,31801,31804,31805,31806,31807,31808,31809,31901,31906,30903,30904,41003,41004,41011,41012,41301,31001,31002,31010,31011,31012,31013,31014,31015,31017,31018,31019,31020,41009,42001,42003,42004,52301 EUDAMED31904-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244542127 EUDAMED
- Basic UDI-DI
- 697124454UpperExtremityXM EUDAMED
- Direct Marketing DI
- 06971244542127 EUDAMED
- EMDN Code
- Y060603 FINGERS 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
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
SIMPLE Thumb brace W4 by Simple Medical (Shenzhen) Limited — 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 | 697124454UpperExtremityXM | Class I | Active |
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Manufacturer
- Manufacturer
- Simple Medical (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000013198
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 251ac992-1beb-4638-a1eb-e41cf121fe70 61 fields · synced Jul 27, 2026