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Hygenic FR Framed Dental Dam Non-Latex, Purple, 1/PK Sample
EUDAMEDClass I (EU MDR)
Ref 15615Model Dental Dam
Identity
- Trade Name
- Hygenic FR Framed Dental Dam Non-Latex, Purple, 1/PK Sample EUDAMED
- Model / Reference
- Dental Dam EUDAMED15615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00087453997675 EUDAMED
- Basic UDI-DI
- 00874530000000000000023XT EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE 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
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 FR Framed Dental Dam Non-Latex, Purple, 1/PK Sample by The Hygenic Company, LLC — 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 | 00874530000000000000023XT | Class I | Active |
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Manufacturer
- Manufacturer
- The Hygenic Company, LLC
- EUDAMED SRN
- US-MF-000003317
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 20e5876a-30ca-47c6-b595-48cc0a5b1960 61 fields · synced Jul 10, 2026