Identity
- Device Name
- Reusable pressure infusor EUDAMED
- Model / Reference
- H3 EUDAMEDH34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975871860470 EUDAMED06975871860500 EUDAMED06975871860340 EUDAMED06975871860630 EUDAMED06975871860623 EUDAMED06975871860357 EUDAMED06975871860395 EUDAMED06975871860401 EUDAMED06975871860364 EUDAMED06975871860302 EUDAMED06975871860494 EUDAMED06975871860432 EUDAMED06975871860319 EUDAMED06975871860289 EUDAMED06975871860418 EUDAMED06975871860449 EUDAMED06975871860456 EUDAMED06975871860371 EUDAMED
- Basic UDI-DI
- 697587186RIB001TP 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
Reusable 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 | 697587186RIB001TP | 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 (18)
- EUDAMED 4bb7baa1-7d15-4c16-b4dc-c43079cb8a55 61 fields · synced Sep 18, 2026
- EUDAMED 455cb923-38e0-4610-98ff-2ab293a1c052 61 fields · synced May 16, 2026
- EUDAMED bf7dd693-5d76-4a42-aaeb-527d1b803300 61 fields · synced May 16, 2026
- EUDAMED 49d5e7fe-8b89-4adf-9719-0baa8bd7c841 61 fields · synced May 17, 2026
- EUDAMED e0bf801a-a540-4efa-bc9d-1c51dd662adf 61 fields · synced May 17, 2026
- EUDAMED 92dfbb54-19cd-4cee-83de-3ee30dfc36f2 61 fields · synced May 17, 2026
- EUDAMED 99f4d24c-3280-473b-b086-954ca22443d3 61 fields · synced May 17, 2026
- EUDAMED 35c2f917-a437-4e1c-905e-c399fdf39799 61 fields · synced May 17, 2026
- EUDAMED 025db918-29e9-4288-aa6f-535983a93ecb 61 fields · synced May 17, 2026
- EUDAMED f20a23a6-9e63-4c04-930a-51266d53944b 61 fields · synced May 18, 2026
- EUDAMED 9fe2f6f1-6770-4748-9886-bf5d3b6aac8a 61 fields · synced May 18, 2026
- EUDAMED ffde601f-6d65-4015-89df-e03004913af1 61 fields · synced May 19, 2026
- EUDAMED c69f1978-7eaa-418b-9a69-f132984f1e42 61 fields · synced May 19, 2026
- EUDAMED 16f0d18c-adc7-484a-af30-5a14db7ac832 61 fields · synced May 19, 2026
- EUDAMED d13ba8dc-c31b-46fc-85d9-278058163780 61 fields · synced May 19, 2026
- EUDAMED 6dc4ea37-be53-4ae4-9578-fe4a3fd07ad7 61 fields · synced May 19, 2026
- EUDAMED 650c8e1f-c2fc-4ba5-949c-aa527f1e3e10 61 fields · synced May 19, 2026
- EUDAMED aac2e75a-f76e-4ac9-b2f0-a7fac0d65d3b 61 fields · synced May 19, 2026