Identity
- Device Name
- Disposable pressure infusor EUDAMED
- Model / Reference
- H3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975871860609 EUDAMED
- Basic UDI-DI
- 697587186DIB001MZ EUDAMED
- EMDN Code
- B0499 AUTOTRANSFUSION DEVICES - 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
Disposable pressure infusor by Ningbo KK-Bioscience 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 | 697587186DIB001MZ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo KK-Bioscience Co., Ltd.
- EUDAMED SRN
- CN-MF-000016962
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED c42a8b6e-0cf3-4987-8a7d-8de6cd0a5909 61 fields · synced Jun 19, 2026