← Back to catalogue
Faja Embarazada PRIMSPINE MAMMY, gris
EUDAMEDFDA UDIClass I (EU MDR)
Ref PRS615G OS
by Prim, S.a.
Identity
- Trade Name
- Faja Embarazada PRIMSPINE MAMMY, gris EUDAMEDPrimspine FDA UDI
- Generic Name
- Multiple spinal region orthosis FDA UDI
- Device Name
- Fajas EUDAMEDPRIMSPINE MAMMY Pregnancy Girdle, gray FDA UDI
- Model / Reference
- PRS615G OS EUDAMEDFDA UDI
- Description
- PRIMSPINE MAMMY Pregnancy Girdle, gray FDA UDI
Identifiers
- Catalog Number
- 824726 FDA UDI
- Primary DI / UDI-DI
- 08434048352784 EUDAMEDFDA UDI
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- FDA Product Code
- QSB FDA UDI
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
- GMDN Term
- Multiple spinal region orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Faja Embarazada PRIMSPINE MAMMY, gris by Prim S.a. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843404825FAJAC4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (3)
- EUDAMED 5b70d742-8e6d-4037-a216-caf064aeb820 61 fields · synced Jun 18, 2026
- FDA UDI 28895b0f-1f00-4a51-b4b2-d414e67da849 34 fields · synced May 30, 2026
- EUDAMED 707aba3c-2f79-48f9-9cc0-8015d963cdf9 61 fields · synced Jun 18, 2026