Identity
- Trade Name
- ONCOCARE S EUDAMED
- Device Name
- CLOSED SYSTEM ANTINEOPLATIC DRUG PREPARATION SET -1000ML EUDAMED
- Model / Reference
- ODPS031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680836100314 EUDAMED
- Basic UDI-DI
- B-08680836100314 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: General-purpose suction system, pneumatic
Oncocare S by Oncosem Onkolojik Sistemler San. ve Tic. A.Ş. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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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-08680836100314 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oncosem Onkolojik Sistemler San. ve Tic. A.Ş.
- EUDAMED SRN
- TR-MF-000041122
Sources (1)
- EUDAMED b24bcf98-eccb-4687-8d85-4699bfbda590 61 fields · synced Jun 19, 2026