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Irrigador Flexível
EUDAMEDClass I (EU MDR)
Ref 2LModel 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml
Identity
- Trade Name
- Irrigador Flexível 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
- 06971919468608 EUDAMED
- Basic UDI-DI
- 697191946EK4H EUDAMED
- EMDN Code
- G02060303 BALLOON CATHETERS, BARIUM ENEMA EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Irrigador Flexível 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 a67ee4a5-f6ed-4f1b-a411-6a0df349a2d8 61 fields · synced Jul 9, 2026