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HYGENIC FR Framed Dental Dam Non-Late Purple 20/pk
EUDAMEDClass I (EU MDR)
Ref 15514Model Dental Dam
Identity
- Trade Name
- HYGENIC FR Framed Dental Dam Non-Late Purple 20/pk EUDAMED
- Model / Reference
- Dental Dam EUDAMED15514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10087453155140 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-Late Purple 20/pk 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 b9fbe49d-6f77-4ed6-9b8e-01b12be4981f 61 fields · synced Jun 19, 2026