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HYGENIC HR Dental Dam Non-Latex 5x5 Teal 15/pk
EUDAMEDClass I (EU MDR)
Ref 15552Model Dental Dam
Identity
- Trade Name
- HYGENIC HR Dental Dam Non-Latex 5x5 Teal 15/pk EUDAMED
- Model / Reference
- Dental Dam EUDAMED15552 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10087453155522 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 HR Dental Dam Non-Latex 5x5 Teal 15/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 f1fcf8dd-d3ca-468c-bfd7-297748db515b 61 fields · synced Jun 18, 2026