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Enema Irrigator
EUDAMEDClass I (EU MDR)
Ref 2TModel 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml
Identity
- Trade Name
- Enema Irrigator EUDAMED
- Device Name
- Enema Kit EUDAMED
- Model / Reference
- 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml EUDAMED2T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919462378 EUDAMED
- Basic UDI-DI
- 697191946EK4H EUDAMED
- EMDN Code
- A020299 REUSABLE SYRINGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia 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
Enema Irrigator 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 15ffdda2-b079-4843-932a-5f09c81e9d62 61 fields · synced Jun 19, 2026