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proKlene Regular Prophylaxis Paste Coarse Orange 250g

EUDAMED

Class I (EU MDR)

Ref AH1400Ref WDAH1400Ref AH1400-PRef AH1400-T

by Advanced Healthcare Ltd.

Identity

Trade Name
proKlene Regular Prophylaxis Paste Coarse Orange 250g EUDAMED
Device Name
Oral Hygiene Products - Prophylaxis pastes EUDAMED
Model / Reference
AH1400 EUDAMED
WDAH1400 EUDAMED
AH1400-P EUDAMED
AH1400-T EUDAMED

Identifiers

Primary DI / UDI-DI
05060446606483 EUDAMED
05060446608753 EUDAMED
05060446606513 EUDAMED
05060446609163 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 Coarse Orange 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

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Manufacturer

Manufacturer
Advanced Healthcare Ltd.
EUDAMED SRN
GB-MF-000002771
Authorised Representative
Advena Limited MT-AR-000000234

Sources (4)

  • EUDAMED 7c89f3c4-c43b-452c-a7c8-dfe6c958367e 61 fields · synced Jul 31, 2026
  • EUDAMED a76ed4cc-4358-45ba-aacc-ff6735ca82d0 61 fields · synced May 18, 2026
  • EUDAMED 52b2d344-425f-44b5-b242-cd326e453455 61 fields · synced May 19, 2026
  • EUDAMED 366f8f8a-f9bf-4ba6-9b45-ab90f069b725 61 fields · synced May 19, 2026