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Intraoral Camera Sleeves/ RA Curing Light Sleeves
EUDAMEDClass I (EU MDR)
Ref 125Ref 125SS
Identity
- Trade Name
- Intraoral Camera Sleeves/ RA Curing Light Sleeves EUDAMED
- Device Name
- Barrier Sleeves EUDAMED
- Model / Reference
- 125 EUDAMED125SS EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1251252 EUDAMED+D125125SS2 EUDAMED
- Basic UDI-DI
- ++D125BRSLEEVE2W EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER 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
Intraoral Camera Sleeves/ RA Curing Light Sleeves 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 | ++D125BRSLEEVE2W | 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 (2)
- EUDAMED d750ae35-3c7c-41cc-a886-66f10eb79b31 61 fields · synced Oct 6, 2026
- EUDAMED cdda1df9-1bd0-4bfc-8c21-df1a6d86b3d1 61 fields · synced May 17, 2026