Identity
- Trade Name
- Endo Sponges EUDAMED
- Device Name
- Endo Instrument Holders EUDAMED
- Model / Reference
- 812 EUDAMED811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D1258122 EUDAMED+D1258112 EUDAMED
- Basic UDI-DI
- ++D125ENDOINSTHOLDERSGF EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - 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
Endo Sponges 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 | ++D125ENDOINSTHOLDERSGF | 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 6ecb6072-9d52-4709-8d79-44984a62cfeb 61 fields · synced Jul 21, 2026
- EUDAMED c42f7bd1-7c75-4024-9688-ceeaa0c3ddde 61 fields · synced May 18, 2026