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Plasti-med
EUDAMEDClass IIa (EU MDR)
Ref 101 012
by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.
Identity
- Trade Name
- Plasti-med EUDAMED
- Device Name
- SOFT DRAIN 12 CH 100 cm W/ DRAINAGE BAG EUDAMED
- Model / Reference
- 101 012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698573030221 EUDAMED
- Basic UDI-DI
- B-08698573030221 EUDAMED
- EMDN Code
- A0601010403 FLAT AND LAMELLAR DRAINAGES 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: Closed-wound drain, non-bioabsorbable
Plasti-med by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08698573030221 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000032251
Sources (1)
- EUDAMED b99f94cf-39a8-424b-bdeb-103b2e23f19d 61 fields · synced Jun 17, 2026