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010205-701108
EUDAMEDClass IIa (EU MDR)
Ref 010205-701108Model KL-8019-CT-200/200-Mark ARef 010203Ref 010205-701207Ref 010203-701107
Identity
- Model / Reference
- KL-8019-CT-200/200-Mark A EUDAMED010205-701108 EUDAMED010203 EUDAMED010205-701207 EUDAMED010203-701107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937137112402 EUDAMED06937137112204 EUDAMED06937137112419 EUDAMED06937137112235 EUDAMED
- Basic UDI-DI
- 697039294010205-701108BR EUDAMED697039294010203SF EUDAMED697039294010205-701207BU EUDAMED697039294010203-701107AH 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
010205-701108 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 | 697039294010205-701108BR | 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 (4)
- EUDAMED fca7b0ea-b0fa-4d86-9a68-3d26b5fce148 61 fields · synced Oct 6, 2026
- EUDAMED 353f5a52-831b-468e-b169-8b7542d1760c 61 fields · synced May 16, 2026
- EUDAMED b7ff8094-5d60-40a0-80a1-603b1df08aad 61 fields · synced May 17, 2026
- EUDAMED d51665d1-0db7-4c1c-b6d0-80a49b082b51 61 fields · synced May 18, 2026