← Back to catalogue
Plasti-Med
EUDAMEDClass IIa (EU MDR)
Ref 101022
by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.
Identity
- Trade Name
- PLASTI-MED EUDAMED
- Device Name
- SOFT DRAIN 22 CH 100 cm W/ DRAINAGE BAG EUDAMED
- Model / Reference
- 101022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698573030283 EUDAMED
- Basic UDI-DI
- B-08698573030283 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
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
- Argyle — Cardinal Health 200, LLC · Class II
- ReSolve® — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Argyle — Cardinal Health 200, LLC · Class II
- Silicone Vac Drain, Round — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
- SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- Exodus — NAVILYST MEDICAL, INC. · Class II
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-08698573030283 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000032251
Sources (1)
- EUDAMED 54e24393-fb6d-47f2-bffe-5c5f56bff983 61 fields · synced Jun 20, 2026