Identity
- Device Name
- Orthodontic Instruments, Reusable EUDAMED
- Model / Reference
- 18-N2-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973329322181 EUDAMED
- Basic UDI-DI
- 697332932OIR2932S3 EUDAMED
- Direct Marketing DI
- 06973329322181 EUDAMED
- EMDN Code
- L150702 ORTHODONTIC PLIERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Orthodontic Instruments, Reusable by Astar Orthodontics Inc. — 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 | 697332932OIR2932S3 | Class I | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (1)
- EUDAMED 3f4b8566-3a16-4b50-a1b9-e860b44f1a27 61 fields · synced Jun 19, 2026