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Dentapreg® SFM Double Pack
EUDAMEDClass IIa (EU MDR)
Ref D-302Ref D-301
by ADM, a.s.
Identity
- Trade Name
- Dentapreg® SFM Double Pack EUDAMED
- Device Name
- Dentapreg® SFM EUDAMED
- Model / Reference
- D-302 EUDAMEDD-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595652700207 EUDAMED
- Basic UDI-DI
- 85956527SFM9H EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Dentapreg® SFM Double Pack by ADM, a.s. — 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 | 85956527SFM9H | Class IIa | Active |
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Manufacturer
- Manufacturer
- ADM, a.s.
- EUDAMED SRN
- CZ-MF-000032589
Sources (2)
- EUDAMED 5a37151f-50fd-497b-b62c-dfa55e7ad432 61 fields · synced Jul 8, 2026
- EUDAMED 57193e33-590f-478c-8617-9f9483e49867 61 fields · synced Jun 18, 2026