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Medical plastic trays
EUDAMEDClass I (EU MDR)
Ref /Model APT01,AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20,DPT01,DPT02,DPT03,DPT04,NC01
Identity
- Trade Name
- Medical plastic trays EUDAMED
- Device Name
- Medical plastic trays EUDAMED
- Model / Reference
- APT01,AK01, AK01 16, AK01 16a, AK01 17, AK01 18, AK01 19, AK01 20,DPT01,DPT02,DPT03,DPT04,NC01 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001462 EUDAMED
- Basic UDI-DI
- 69544540MEPT001UF EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Medical plastic trays by Huanghua Promisee Dental Co.Ltd. — Class I — CE/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 | 69544540MEPT001UF | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 6d790443-4e52-488e-aeed-ef335b2c8963 61 fields · synced Oct 7, 2026