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Arti-Fol®
EUDAMEDClass I (EU MDR)
Ref BK 1021Model Arti-Fol®Ref BK 25Ref BK 76Ref BK 20Ref BK 26Ref BK 1026Ref BK 1022Ref BK 77Ref BK 1027Ref BK 73Ref BK 24
Identity
- Trade Name
- Arti-Fol® EUDAMED
- Model / Reference
- Arti-Fol® EUDAMEDBK 1021 EUDAMEDBK 25 EUDAMEDBK 76 EUDAMEDBK 20 EUDAMEDBK 26 EUDAMEDBK 1026 EUDAMEDBK 1022 EUDAMEDBK 77 EUDAMEDBK 1027 EUDAMEDBK 73 EUDAMEDBK 24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E210BK102118 EUDAMED+E210BK251B EUDAMED+E210BK761H EUDAMED+E210BK2016 EUDAMED+E210BK261C EUDAMED+E210BK10261D EUDAMED+E210BK102219 EUDAMED+E210BK771I EUDAMED+E210BK10271E EUDAMED+E210BK731E EUDAMED+E210BK241A 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® 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 (11)
- EUDAMED 3cd55166-43a3-46de-889e-999064a0b633 61 fields · synced Oct 7, 2026
- EUDAMED 46fb3d80-bccb-43c8-a834-e00fb3d15a07 61 fields · synced May 16, 2026
- EUDAMED fbc14a84-4738-4658-bed7-ac2db54c2e74 61 fields · synced May 17, 2026
- EUDAMED 442f98f3-01e9-41da-80e3-7e8df980299b 61 fields · synced May 17, 2026
- EUDAMED c22de63a-3b02-4947-a388-12394eed2004 61 fields · synced May 17, 2026
- EUDAMED b6d2e954-94f8-4067-a3f5-5fbe24928532 61 fields · synced May 18, 2026
- EUDAMED d5655a64-0ab4-4f9a-bf44-4d2235b641d8 61 fields · synced May 18, 2026
- EUDAMED 1b599cd0-a099-4aa2-b9f4-f7a1e7865f33 61 fields · synced May 18, 2026
- EUDAMED cbbc2f7e-2e9b-4f4d-bc59-5e918fdbee43 61 fields · synced May 19, 2026
- EUDAMED 9f60d173-4ef2-4eef-b103-b7fc83c2f0f8 61 fields · synced May 19, 2026
- EUDAMED b8ed0973-3fe8-45b3-9d26-50983123b6e7 61 fields · synced May 19, 2026