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Enteroclisma Dual-2lt
EUDAMEDClass I (EU MDR)
Ref 2LModel 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml
Identity
- Trade Name
- ENTEROCLISMA DUAL-2LT EUDAMED
- Device Name
- Enema Kit EUDAMED
- Model / Reference
- 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml EUDAMED2L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919462484 EUDAMED
- Basic UDI-DI
- 697191946EK4H EUDAMED
- EMDN Code
- A020299 REUSABLE SYRINGES - OTHER 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
Enteroclisma Dual-2lt 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 | 697191946EK4H | 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 (1)
- EUDAMED 44874750-c337-4de0-abbd-4616d7ed406a 61 fields · synced Jun 17, 2026