Identity
- Device Name
- Portable suction machine EUDAMED
- Model / Reference
- 9K-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977301880218 EUDAMED
- Basic UDI-DI
- 697730188PSM02QJ EUDAMED
- EMDN Code
- Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Portable suction machine by Jiangsu Jingyi Medical Technology Co., Ltd — Class IIa — 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 | 697730188PSM02QJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Jingyi Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000044145
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED af4bf9db-d8ad-42ed-99a1-b540bef6f953 61 fields · synced Jul 29, 2026