Identity
- Trade Name
- Arti-Fol® metallic EUDAMED
- Model / Reference
- Arti-Fol® EUDAMEDBK 1028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E210BK10281F EUDAMED
- Basic UDI-DI
- ++E2102x0xFilmx8x12x16D5 EUDAMED
- EMDN Code
- Q01020299 DENTAL CONTACT INDICATORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Arti-Fol® metallic by Dr. Jean Bausch GmbH & Co. KG — Class I — 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 | ++E2102x0xFilmx8x12x16D5 | Class I | Active |
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Manufacturer
- Manufacturer
- Dr. Jean Bausch GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005577
Sources (1)
- EUDAMED 41265c3f-65b0-439d-b5fb-d1ab4f0ae82b 61 fields · synced Jun 18, 2026