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Multi-Use Tubing System Kits
EUDAMEDClass IIa (EU MDR)
Ref HT-L5002Model AGT1-I、AGT1-II、 AGT2、AGT2-I、AGT2-II、AGT2-III、BF2、BF2-I、AI、AII
Identity
- Trade Name
- Multi-Use Tubing System Kits EUDAMED
- Device Name
- Multi-Use Tubing System Kit EUDAMED
- Model / Reference
- AGT1-I、AGT1-II、 AGT2、AGT2-I、AGT2-II、AGT2-III、BF2、BF2-I、AI、AII EUDAMEDHT-L5002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938327978129 EUDAMED
- Basic UDI-DI
- 69383279217XQ EUDAMED
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Multi-Use Tubing System Kits by Shenzhen Boon Medical Supply Co., Ltd. — Class IIa — 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 | 69383279217XQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000018400
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 30f19c4c-ed4d-43c7-9016-54289d89ef2a 61 fields · synced Oct 7, 2026