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Seal Temp
EUDAMEDClass IIa (EU MDR)
Ref STD-8Model Seal TempRef STD-16
by G-Pharma
Identity
- Trade Name
- Seal Temp EUDAMEDSEALTEMP EUDAMED
- Device Name
- Temporary resin-based luting cements EUDAMED
- Model / Reference
- Seal Temp EUDAMEDSTD-8 EUDAMEDSTD-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664933001489 EUDAMED03664933001472 EUDAMED
- Basic UDI-DI
- 3664933ST-S01XQ EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Seal Temp by G-Pharma — 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 | 3664933ST-S01XQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- G-Pharma
- EUDAMED SRN
- FR-MF-000017094
Sources (2)
- EUDAMED c893e3d8-62fd-4487-bc29-b52fd193a4a8 61 fields · synced Jul 30, 2026
- EUDAMED a94956f9-8cab-40b4-9f10-5e69a7cb93b3 61 fields · synced Jul 30, 2026