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Primspine Gold
EUDAMEDClass I (EU MDR)
Ref PRS646G XXXLRef PRS646G MRef PRS640G SRef PRS646G XXLRef PRS646G SRef PRS646G L
by Prim, S.a.
Identity
- Trade Name
- PRIMSPINE GOLD EUDAMEDFaja Lumbosacra PRIMSPINE GOLD, tensor doble S EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- PRS646G XXXL EUDAMEDPRS646G M EUDAMEDPRS640G S EUDAMEDPRS646G XXL EUDAMEDPRS646G S EUDAMEDPRS646G L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048371952 EUDAMED08434048371914 EUDAMED08434048371686 EUDAMED08434048371945 EUDAMED08434048371907 EUDAMED08434048371921 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE ORTHOSES EUDAMEDY060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Primspine Gold 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 | 843404825FAJAC4 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (6)
- EUDAMED 253282fa-8c73-4473-b55c-bfbf1d9cd9b7 61 fields · synced Sep 17, 2026
- EUDAMED f6515478-b511-446a-bcaf-4c82acadf710 61 fields · synced May 16, 2026
- EUDAMED 23066ca4-e3ac-46d4-bda8-00509af91b45 61 fields · synced May 17, 2026
- EUDAMED d8475c19-7cdf-4cc8-a9b6-dc347f8ef159 61 fields · synced May 17, 2026
- EUDAMED 0e64d05b-60dc-4fca-a243-d1220abc7554 61 fields · synced May 18, 2026
- EUDAMED 4eb3f2d5-1023-4df4-ada8-45ecd0cba525 61 fields · synced May 19, 2026