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Opasi̇l™
EUDAMEDClass I (EU MDR)
Ref 345543Model Ostomy Paste
by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- OPASİL™ EUDAMED
- Device Name
- Ostomy Paste EUDAMED
- Model / Reference
- Ostomy Paste EUDAMED345543 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680495075930 EUDAMED08680495075893 EUDAMED
- Basic UDI-DI
- 8680495072OPQF EUDAMED
- EMDN Code
- A108008 ADHESIVES FOR ABDOMINAL OSTOMY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Opasi̇l™ by Geli̇şi̇m Medi̇kal Tibbi̇ Malz. Paz. San. Ve Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8680495072OPQF | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000037637
Sources (2)
- EUDAMED 1e379b9b-196a-4e42-bf53-0973604003f8 61 fields · synced Oct 6, 2026
- EUDAMED 126cc78c-5cf8-45bb-bd42-5395b5bdb8c2 61 fields · synced May 19, 2026