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SIMPLE Cervical Collar C2
EUDAMEDClass I (EU MDR)
Ref 50110-LModel 51001,51002,51007,51301,51302,51304,51320,51325,52001,52002,52003,52006,52008,52009,52013,52024,52025,52026
Identity
- Trade Name
- SIMPLE Cervical Collar C2 EUDAMED
- Device Name
- SIMPLE Cervical Collar C2, SIMPLE Cervical Collar C1, VertiComfort Collar 172, SIMPLE TLSO 301, VertiComfort TLSO464 , VertiComfort TLSO 456, SIMPLE Cryo TLSO 456, SIMPLE Cryo TLSO 464, VertiComfort LSO 625, SIMPLE LO105, VertiComfort LSO 631 EUDAMED
- Model / Reference
- 51001,51002,51007,51301,51302,51304,51320,51325,52001,52002,52003,52006,52008,52009,52013,52024,52025,52026 EUDAMED50110-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244543742 EUDAMED
- Basic UDI-DI
- 697124454SpineOrthoses7Y EUDAMED
- Direct Marketing DI
- 06971244543742 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE 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 Cervical Collar C2 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 | 697124454SpineOrthoses7Y | 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 95ed5461-a64d-40e5-8430-00e4553a86e5 61 fields · synced Aug 3, 2026