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proKlene Regular Prophylaxis Paste Medium Mint 250g
EUDAMEDClass I (EU MDR)
Ref AH1401-PRef AH1401-TRef AH1401
Identity
- Trade Name
- proKlene Regular Prophylaxis Paste Medium Mint 250g EUDAMED
- Device Name
- Oral Hygiene Products - Prophylaxis pastes EUDAMED
- Model / Reference
- AH1401-P EUDAMEDAH1401-T EUDAMEDAH1401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446606506 EUDAMED05060446607756 EUDAMED05060446606490 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 250g 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 6c515e10-de17-44e4-b506-3a3faf258e65 61 fields · synced Sep 17, 2026
- EUDAMED 0af4f903-78ce-4490-bac2-0ca6fe4c75c7 61 fields · synced May 17, 2026
- EUDAMED e00f9bc8-df95-4476-b294-906348cce37b 61 fields · synced May 17, 2026