Identity
- Device Name
- Buccal (Shape H) EUDAMED
- Model / Reference
- 1150987 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G15511509870 EUDAMED
- Basic UDI-DI
- ++G1551150987QU EUDAMED
- EMDN Code
- L160299 DIAGNOSTIC USE MIRRORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Buccal (Shape H) by Nadir & CO — 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 | ++G1551150987QU | Class I | Active |
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Manufacturer
- Manufacturer
- Nadir & CO
- EUDAMED SRN
- PK-MF-000026725
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED a4fe64d3-78cf-448f-90d4-c8aa19ed1663 61 fields · synced Jul 10, 2026