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proKlene Regular Prophylaxis Paste Medium Mint 50g
EUDAMEDClass I (EU MDR)
Ref AH1426-PRef AH1426Ref AH1426-T
Identity
- Trade Name
- proKlene Regular Prophylaxis Paste Medium Mint 50g EUDAMED
- Device Name
- Oral Hygiene Products - Prophylaxis pastes EUDAMED
- Model / Reference
- AH1426-P EUDAMEDAH1426 EUDAMEDAH1426-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446607923 EUDAMED05060446607046 EUDAMED05060446609132 EUDAMED
- Basic UDI-DI
- 5056009120039SE EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
proKlene Regular Prophylaxis Paste Medium Mint 50g by Advanced Healthcare Ltd. — 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 | 5056009120039SE | Class I | Active |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 0c3cb3ce-e580-4f3a-ad7f-e9ae461d702f 61 fields · synced Aug 1, 2026
- EUDAMED 26d6bc2b-7563-45f3-8f8e-a2e14b53acce 61 fields · synced May 17, 2026
- EUDAMED dffc4b92-385e-410a-b1bf-47f47a4ea6f6 61 fields · synced May 17, 2026