Identity
- Trade Name
- RUBBER DAM FRAME EUDAMEDRUBBER DAM FRAME BIG EUDAMED
- Device Name
- RUBBER DAM FRAME EUDAMEDRUBBER DAM FRAME BIG EUDAMED
- Model / Reference
- 1001-17B EUDAMED1007-17C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D123100117B0 EUDAMEDD123100717C0 EUDAMED
- Basic UDI-DI
- ++D123100117BFY EUDAMED++D123100717CHC EUDAMED
- EMDN Code
- L15901102 DAM POSITIONING INSTRUMENTS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Rubber Dam Frame by Dental Expert — 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 | ++D123100117BFY | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (2)
- EUDAMED 3905b325-49fb-40b7-9ae5-d49f0027831d 61 fields · synced Jul 15, 2026
- EUDAMED a7527c93-814f-40f7-a987-4d73e3e2d754 61 fields · synced May 18, 2026