Identity
- Trade Name
- Bite Wing Loops EUDAMED
- Device Name
- X-Ray Film Holders EUDAMED
- Model / Reference
- 2012-2 EUDAMED2012-1 EUDAMED2011-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D125201222 EUDAMED+D125201212 EUDAMED+D125201112 EUDAMED
- Basic UDI-DI
- ++D125FILMHOLDERKK EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Z11079085 VARIOUS X-RAY FILM IMAGING SUPPORT INSTRUMENTS - CONSUMABLES 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
Bite Wing Loops 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 | ++D125FILMHOLDERKK | 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 (3)
- EUDAMED 28b13970-d79b-4572-b043-6455cf7ad1b3 61 fields · synced Jul 31, 2026
- EUDAMED 776bbfe3-f60a-4001-aa90-2433acfd2b7f 61 fields · synced May 17, 2026
- EUDAMED e0341865-c793-4d4c-bbf5-03619041face 61 fields · synced May 17, 2026