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Arti-Fol® metallic
EUDAMEDClass I (EU MDR)
Ref BK 33Model Arti-Fol®Ref BK 35Ref BK 731Ref BK 730Ref BK 32Ref BK 30
Identity
- Trade Name
- Arti-Fol® metallic EUDAMED
- Model / Reference
- Arti-Fol® EUDAMEDBK 33 EUDAMEDBK 35 EUDAMEDBK 731 EUDAMEDBK 730 EUDAMEDBK 32 EUDAMEDBK 30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E210BK331A EUDAMED+E210BK351C EUDAMED+E210BK7311F EUDAMED+E210BK7301E EUDAMED+E210BK3219 EUDAMED+E210BK3017 EUDAMED
- Basic UDI-DI
- ++E2102x0xFilmx8x12x16D5 EUDAMED
- Unit of Use DI
- +E210BK350B 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 (6)
- EUDAMED d67da7de-6e72-4e87-89bf-6e48f5250701 61 fields · synced Oct 6, 2026
- EUDAMED 3d2836d1-d666-4c8e-afbb-a966ea5286b8 61 fields · synced May 17, 2026
- EUDAMED 418e37b3-9ffb-4384-9312-3f2fbf058299 61 fields · synced May 17, 2026
- EUDAMED 21cb04cc-33e6-4fed-a23d-648419dded38 61 fields · synced May 18, 2026
- EUDAMED dc1efd36-3718-4c6e-bcec-1e2a865b369d 61 fields · synced May 18, 2026
- EUDAMED 78e14b00-0596-4c09-8c7b-cc7bb046b606 61 fields · synced May 19, 2026