Identity
- Model / Reference
- KL-8019-CT-200/200-Mark B EUDAMED010214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937137112549 EUDAMED
- Basic UDI-DI
- 697039294010214SL EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiography kit
010214 by Jiangsu Kangle Medical Device Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697039294010214SL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Kangle Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000041147
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 4570e197-d499-4fc8-968d-fd337f35273f 61 fields · synced Jul 11, 2026