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Cervical Collar /Neck Brace/Soft collar
EUDAMEDClass I (EU MDR)
Ref NK-SF-12 LModel Neck brace/Cervical Collar /Philedelphia Collar Ref NK-SF-12 MRef NK-SF-14 LRef NK-SF-14 SRef NK-SF-11 MRef NK-SF-11 LRef NK-SF-14 XL
Identity
- Trade Name
- Cervical Collar /Neck Brace/Soft collar EUDAMED
- Device Name
- Neck brace/Cervical Collar /Philedelphia Collar EUDAMED
- Model / Reference
- Neck brace/Cervical Collar /Philedelphia Collar EUDAMEDNK-SF-12 L EUDAMEDNK-SF-12 M EUDAMEDNK-SF-14 L EUDAMEDNK-SF-14 S EUDAMEDNK-SF-11 M EUDAMEDNK-SF-11 L EUDAMEDNK-SF-14 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719961662443 EUDAMED04719961662436 EUDAMED04719961662481 EUDAMED04719961662467 EUDAMED04719961661682 EUDAMED04719961661699 EUDAMED04719961662498 EUDAMED
- Basic UDI-DI
- 471996166NECKMA EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Cervical Collar /Neck Brace/Soft collar by Irufa Industrial Group 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 | 471996166NECKMA | Class I | Active |
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Manufacturer
- Manufacturer
- Irufa Industrial Group CO., LTD.
- EUDAMED SRN
- TW-MF-000046083
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (7)
- EUDAMED 3a21fd51-1f45-47e0-b701-048ca870c245 61 fields · synced Oct 6, 2026
- EUDAMED c06c6282-6835-4d79-80ad-ca4c9b6be19d 61 fields · synced May 16, 2026
- EUDAMED 081957c6-2cd4-4df5-89e9-6d94527620fa 61 fields · synced May 17, 2026
- EUDAMED a01dc142-6cca-4027-9219-13df1c5b1f1c 61 fields · synced May 17, 2026
- EUDAMED c9eded4b-15ac-4815-bb13-f8a32c2be0e4 61 fields · synced May 18, 2026
- EUDAMED 773f9c3b-7586-4f4f-9412-57c9bc57796f 61 fields · synced May 18, 2026
- EUDAMED dcb82b10-5ca8-430f-b6d3-61783f2582b1 61 fields · synced May 19, 2026