Identity
- Trade Name
- Heuer EUDAMED
- Device Name
- Karman Cannula- 12mm EUDAMED
- Model / Reference
- KC12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89044078000224 EUDAMED
- Basic UDI-DI
- 89044078KC12PV EUDAMED
- EMDN Code
- U080199 GYNAECOLOGICAL CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heuer by G.S.T. Corporation Limited — Class IIa — CE/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 | 89044078KC12PV | Class IIa | Active |
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Manufacturer
- Manufacturer
- G.S.T. Corporation Limited
- EUDAMED SRN
- IN-MF-000040767
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED d561af68-c4be-4076-98e0-c12c4e7a8c07 61 fields · synced Oct 7, 2026