Identity
- Model / Reference
- Single connecting tube EUDAMED0601008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937137116905 EUDAMED
- Basic UDI-DI
- 6970392940601008PX 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
0601008 by Jiangsu Kangle Medical Device Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Angiography kit.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- NAMIC — NAVILYST MEDICAL, INC.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 | 6970392940601008PX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 4a6f762a-2ffd-4234-a505-7c604c87eca2 61 fields · synced Jul 20, 2026