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Clearsafe Comfort
EUDAMEDClass IIa (EU MDR)
Ref 0927Model Safety Intravenous catheter/IV Catheter/Safety IV Cannula
Identity
- Trade Name
- Clearsafe Comfort EUDAMED
- Device Name
- Safety Intravenous catheter/IV Catheter/Safety IV Cannula EUDAMED
- Model / Reference
- Safety Intravenous catheter/IV Catheter/Safety IV Cannula EUDAMED0927 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904399109271 EUDAMED
- Basic UDI-DI
- 89043991HSIVC023U EUDAMED
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Clearsafe Comfort by Harsoria Healthcare Pvt. 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 | 89043991HSIVC023U | Class IIa | Active |
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Manufacturer
- Manufacturer
- Harsoria Healthcare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000018349
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 2764c7f9-5f6a-4af4-9aa7-2e252c3f05f4 61 fields · synced Oct 6, 2026