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Imagemate CT-Pro Hose Tubing System
EUDAMEDClass IIa (EU MDR)
Ref ImageCT-325-L
Identity
- Trade Name
- Imagemate CT-Pro Hose Tubing System EUDAMED
- Device Name
- Imagemate CT-Pro Hose Tubing System EUDAMED
- Model / Reference
- ImageCT-325-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973955107428 EUDAMED
- Basic UDI-DI
- 697395510CICD1JL EUDAMED
- Direct Marketing DI
- 86973955107424 EUDAMED
- EMDN Code
- Z11039085 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Imagemate CT-Pro Hose Tubing System by Suzhou Hengrui Hongyuan Medical Co., Ltd. — 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 | 697395510CICD1JL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Hengrui Hongyuan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000044883
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (1)
- EUDAMED 705f4bed-9f52-49d6-964a-ff1d83969d4e 61 fields · synced Oct 7, 2026