Identity
- Device Name
- T Ortho Primer EUDAMED
- Model / Reference
- T Ortho Primer EUDAMEDFP1032OP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800032400227 EUDAMED
- Basic UDI-DI
- 88000324OPAG EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
T Ortho Primer by Nexobio Co., Ltd. — 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 | 88000324OPAG | Class I | Active |
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Manufacturer
- Manufacturer
- Nexobio Co., Ltd.
- EUDAMED SRN
- KR-MF-000043543
- Authorised Representative
- MEGALİNE DENTAL İTH. İHR. SAN. TİC. LTD. ŞTİ. TR-AR-000046036
Sources (1)
- EUDAMED 21ac87c9-473e-4254-90c3-e7615f05b1e1 61 fields · synced Jun 19, 2026