Identity
- Trade Name
- SIMPLE Cryo Hip EUDAMED
- Device Name
- SIMPLE Hip Brace N3，SIMPLE Hip Brace N4, CryoTreat Hip Brace EUDAMED
- Model / Reference
- 21003，21004，21005 EUDAMED21004-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244544251 EUDAMED
- Basic UDI-DI
- 697124454HipOrthosesQM EUDAMED
- Direct Marketing DI
- 06971244544251 EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION 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 Cryo Hip 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 | 697124454HipOrthosesQM | 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 e186746e-1786-4502-8ddd-377682f0803d 61 fields · synced Jul 20, 2026