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Disposable peel-n-stick sensor holders
EUDAMEDClass I (EU MDR)
Ref 4003Ref 4005Ref 4007Ref 4001Ref PD003934
Identity
- Trade Name
- Disposable peel-n-stick sensor holders EUDAMED
- Device Name
- X-Ray Film Holders EUDAMED
- Model / Reference
- 4003 EUDAMED4005 EUDAMED4007 EUDAMED4001 EUDAMEDPD003934 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D12540034 EUDAMED+D12540054 EUDAMED+D12540074 EUDAMED+D12540014 EUDAMED+D125FIPD0039344 EUDAMED
- Basic UDI-DI
- ++D125FILMHOLDERKK EUDAMED
- Unit of Use DI
- 4 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
Disposable peel-n-stick sensor holders 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 (5)
- EUDAMED 508036c5-835d-4a82-a1bb-18752ab4478f 61 fields · synced Aug 3, 2026
- EUDAMED 89e04db2-deeb-47d8-b11e-6dd0e315d4d9 61 fields · synced May 16, 2026
- EUDAMED c72184d4-1946-4700-936c-8c3c6d3bf41a 61 fields · synced May 17, 2026
- EUDAMED bd028f7c-dc73-4eb8-9cca-6e7b1ab74921 61 fields · synced May 18, 2026
- EUDAMED 4b642ebd-3e8e-4633-8f1c-cfadb7176277 61 fields · synced May 18, 2026