← Back to catalogue
General Surgery Tubing Sets
EUDAMEDClass IIa (EU MDR)
Ref FRIGF2
by Promepla SAM
Identity
- Device Name
- General Surgery Tubing Sets EUDAMED
- Model / Reference
- FRIGF2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512925927 EUDAMED
- Basic UDI-DI
- 037005129GSU-IEXH EUDAMED
- EMDN Code
- Z12029008 GAS INFLATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
General Surgery Tubing Sets by Promepla SAM — Class IIa — 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 | 037005129GSU-IEXH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Promepla SAM
- EUDAMED SRN
- MC-MF-000015769
- Authorised Representative
- Promepla Group S.à r.l. LU-AR-000013458
Sources (1)
- EUDAMED 72e1bb0a-e51a-4296-9821-606c71921991 61 fields · synced Oct 6, 2026