Identity
- Trade Name
- Rubber Dam Frame EUDAMED
- Device Name
- Rubber Dam Frame EUDAMED
- Model / Reference
- 4866 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12548664 EUDAMED
- Basic UDI-DI
- ++D125RUBBERDAMFRAMEWL EUDAMED
- EMDN Code
- L15901102 DAM POSITIONING INSTRUMENTS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Rubber Dam Frame by Premium Plus (Dongguan) Limited — 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 | ++D125RUBBERDAMFRAMEWL | Class I | Active |
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Manufacturer
- Manufacturer
- Premium Plus (Dongguan) Limited
- EUDAMED SRN
- CN-MF-000038259
- Authorised Representative
- Premium Plus Poland sp. z o.o. PL-AR-000030110
Sources (1)
- EUDAMED ba8e13fb-32d6-4e6b-ba65-7b1f38ce988c 61 fields · synced Jul 9, 2026