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HYGENIC Dental Dam 5x5 GREEN Med 52/pk
EUDAMEDClass I (EU MDR)
Ref 15502Model Dental Dam
Identity
- Trade Name
- HYGENIC Dental Dam 5x5 GREEN Med 52/pk EUDAMED
- Model / Reference
- Dental Dam EUDAMED15502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10087453155027 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
Yes
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 Dental Dam 5x5 GREEN Med 52/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 8012cbdd-db9b-44d5-bb8d-5daa8ab2a464 61 fields · synced Aug 2, 2026