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Sterilization pouches and reels
EUDAMEDClass I (EU MDR)
Ref 11-50002Model 11-50001 ~ 11-50083
Identity
- Device Name
- Sterilization pouches and reels EUDAMED
- Model / Reference
- 11-50001 ~ 11-50083 EUDAMED11-50002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974815371560 EUDAMED
- Basic UDI-DI
- 69748153711-50001QR EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Sterilization pouches and reels 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 | 69748153711-50001QR | 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 (1)
- EUDAMED 7e902d8a-4464-488b-a8c5-786accb78df8 61 fields · synced Jun 20, 2026