Identity
- Trade Name
- HYGENIC Medium Soft, #3 Pink Wax, 2.25 kg EUDAMED
- Device Name
- HYGENIC Waxes EUDAMED
- Model / Reference
- H00812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661H008120 EUDAMED
- Basic UDI-DI
- ++D661039KU EUDAMED
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
HYGENIC Medium Soft, #3 Pink Wax, 2.25 kg by Coltene/Whaledent Inc. — 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 | ++D661039KU | Class I | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED f83e9b24-d0aa-465c-9cfa-f3606e89fab7 61 fields · synced Jun 17, 2026