Identity
- Trade Name
- Q01020502 EUDAMED
- Device Name
- Non-sterile Preformed dental crown EUDAMED
- Model / Reference
- EUR-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800156401117 EUDAMED
- Basic UDI-DI
- 88001564ICROWNM3 EUDAMED
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Q01020502 by Seil Global — 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 | 88001564ICROWNM3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seil Global
- EUDAMED SRN
- KR-MF-000013925
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 92b64fa7-8b54-43d5-bb5f-301a4a76f239 61 fields · synced Jun 20, 2026