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Collare Philadelphia 961
EUDAMEDClass I (EU MDR)
Ref 961TI XL 5 1/4"Ref 961TI XL 4 1/4"Ref 961TI XL 3 1/4"Ref 961TI L 5 1/4"Ref 961TI L 4 1/4"Ref 961TI M 5 1/4"Ref 961TI M 4 1/4"Ref 961TI S 4 1/4"
by Prim, S.a.
Identity
- Trade Name
- Collare Philadelphia 961 EUDAMED
- Device Name
- Ortesis Cervicales EUDAMED
- Model / Reference
- 961TI XL 5 1/4" EUDAMED961TI XL 4 1/4" EUDAMED961TI XL 3 1/4" EUDAMED961TI L 5 1/4" EUDAMED961TI L 4 1/4" EUDAMED961TI M 5 1/4" EUDAMED961TI M 4 1/4" EUDAMED961TI S 4 1/4" EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680865845 EUDAMED08426680865838 EUDAMED08426680865821 EUDAMED08426680865722 EUDAMED08426680865715 EUDAMED08426680865760 EUDAMED08426680865753 EUDAMED08426680865791 EUDAMED
- Basic UDI-DI
- 843404825ORTESISCERVIVG EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Collare Philadelphia 961 by Prim S.a. — 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 | 843404825ORTESISCERVIVG | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (8)
- EUDAMED 736e88bf-588e-4cce-939e-473d2ccc9a38 61 fields · synced Oct 7, 2026
- EUDAMED a61edaab-11b8-4ae0-b85c-9d3b24705c8e 61 fields · synced May 16, 2026
- EUDAMED 8c194491-0c07-4c53-810c-b19d6641d1dd 61 fields · synced May 16, 2026
- EUDAMED f8e25f6d-04c8-40af-9f42-5da780a10eec 61 fields · synced May 16, 2026
- EUDAMED 39f2a192-2f47-479f-b513-707c2316feb1 61 fields · synced May 18, 2026
- EUDAMED 11d431d4-d250-4436-bc86-258b085e0089 61 fields · synced May 18, 2026
- EUDAMED 827b92bf-08b7-4310-8d53-92edfbe19842 61 fields · synced May 19, 2026
- EUDAMED f53fd10d-4da8-47d7-b4b5-72d62d633d4d 61 fields · synced May 19, 2026