Identity
- Device Name
- Trantemp Repair EUDAMED
- Model / Reference
- Trantemp Repair EUDAMEDFP1015Repair EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800032401729 EUDAMED
- Basic UDI-DI
- 88000324TRB3 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY 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
Trantemp Repair 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 | 88000324TRB3 | 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 70b378c9-8f53-4fdf-8e14-bbbbe74c0459 61 fields · synced Jun 19, 2026