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Prebent Applicator Tip
EUDAMEDClass I (EU MDR)
Ref 11-20003Model 11-20001 ~ 11-20032Ref 11-20006
Identity
- Device Name
- Prebent Applicator Tip EUDAMED
- Model / Reference
- 11-20001 ~ 11-20032 EUDAMED11-20003 EUDAMED11-20006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974815370082 EUDAMED06974815370112 EUDAMED
- Basic UDI-DI
- 69748153711-20001PQ EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDRomania 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
Prebent Applicator Tip by Tribest Dental Products 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 | 69748153711-20001PQ | Class I | Active |
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Manufacturer
- Manufacturer
- Tribest Dental Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 35d5e402-e352-4894-af9c-9a360f7ff60a 61 fields · synced Jul 18, 2026
- EUDAMED 10b8c6bc-a19f-4916-b3b4-a07f28560611 61 fields · synced May 18, 2026