Identity
- Trade Name
- IB-6 EUDAMED
- Device Name
- IB-6 PRP Tube with Gel EUDAMEDIB-6 PRP Tube EUDAMED
- Model / Reference
- GL-1040 EUDAMEDL-1040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M712GL10400T EUDAMED+M712L10401E EUDAMED
- Basic UDI-DI
- B-+M712GL10400T EUDAMEDB-+M712L10401E EUDAMED
- EMDN Code
- B010202 PLATELETS CONCENTRATE TRANSFER BAGS AND KITS EUDAMED
Classification
- Device Class
- Class IIb 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
Ib-6 by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-+M712GL10400T | Class IIb | Active |
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Manufacturer
- Manufacturer
- Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000025066
Sources (2)
- EUDAMED 49b53078-3363-4548-bd64-ca08b5e9d8d1 61 fields · synced Oct 6, 2026
- EUDAMED 6a13407c-40ee-4727-af28-80ebe1dee24d 61 fields · synced May 16, 2026