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Opuss Prx Tubes
EUDAMEDClass IIa (EU MDR)
Ref OP2101Ref OP2001
by T-Bi̇yoteknoloji̇ Laboratuvar Esteti̇k Medi̇kal Kozmeti̇k San. Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- OPUSS PRX TUBES EUDAMED
- Device Name
- OPUSS PRX TUBES EUDAMED
- Model / Reference
- OP2101 EUDAMEDOP2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682754372200 EUDAMED08682754371111 EUDAMED
- Basic UDI-DI
- B-08682754372200 EUDAMEDB-08682754371111 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Opuss Prx Tubes by T-Bi̇yoteknoloji̇ Laboratuvar Esteti̇k Medi̇kal Kozmeti̇k San. Ti̇c. Ltd. Şti̇. — Class IIa — MDD — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682754372200 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016403
Sources (2)
- EUDAMED 22db985f-ee34-4ee1-b8a9-32851b3affad 61 fields · synced Oct 5, 2026
- EUDAMED 77b3253a-0225-4d3a-a462-809a54625e0c 61 fields · synced May 17, 2026