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SIMPLE Post-Op Elbow Brace E1
EUDAMEDClass I (EU MDR)
Ref 41004-FModel 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 Post-Op Elbow Brace E1 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 EUDAMED41004-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244541489 EUDAMED
- Basic UDI-DI
- 697124454UpperExtremityXM EUDAMED
- Direct Marketing DI
- 06971244541489 EUDAMED
- EMDN Code
- Y060615 ELBOW 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 Post-Op Elbow Brace E1 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 c56d859c-7482-4c4d-9d58-1465436d0c9e 61 fields · synced Jun 18, 2026