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Maissafe Valve
EUDAMEDClass IIa (EU MDR)
Ref MI/CA/01-000-EModel Safety IV Cannula with/without Injection Port & with/without wings/with blood control/with instant flashback/with Small Safety Device/with Metallic Clips
Identity
- Trade Name
- Maissafe Valve EUDAMED
- Device Name
- IV Cannula/Catheter with Safety Features EUDAMED
- Model / Reference
- Safety IV Cannula with/without Injection Port & with/without wings/with blood control/with instant flashback/with Small Safety Device/with Metallic Clips EUDAMEDMI/CA/01-000-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906065486563 EUDAMED
- Basic UDI-DI
- 890606548I10LT EUDAMED
- Direct Marketing DI
- 08906065486563 EUDAMED
- EMDN Code
- C0101010201 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia 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
Maissafe Valve by Mais India Medical Devices 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 | 890606548I10LT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mais India Medical Devices Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000021842
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 91280c8a-6dcf-4365-b3e6-f60193de04a2 61 fields · synced Jun 19, 2026