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disposable pressure infuser
EUDAMEDClass I (EU MDR)
Ref 1000AGSFLEXModel 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000mlRef 500AGSFLEX
Identity
- Trade Name
- disposable pressure infuser EUDAMED
- Device Name
- Pressure Infusion Cuff EUDAMED
- Model / Reference
- 100ml, 200ml, 300ml, 500ml, 600ml, 700ml, 800ml, 1000ml, 1500ml, 2000ml, 3000ml, 4000ml, 5000ml EUDAMED1000AGSFLEX EUDAMED500AGSFLEX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919460367 EUDAMED06971919460213 EUDAMED
- Basic UDI-DI
- 697191946PICVH EUDAMED
- EMDN Code
- A088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
disposable pressure infuser by Ningbo Albert Novosino Co., Ltd. — Class I — 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 | 697191946PICVH | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 6ec58924-56e5-420f-88f1-ef3f999950f6 61 fields · synced Sep 30, 2026
- EUDAMED 450c60ef-3b09-44b9-8978-259b92c4b5fc 61 fields · synced May 19, 2026