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Medical ultrasnoic couplant
EUDAMEDClass I (EU MDR)
Ref 20gModel 12g、15g、20g、30g、50g、60g、80g、100g、120g、150g、200g、250g、300g、500g、1kg、2.5kg、5kg、10kg、20kg,or customized
Identity
- Trade Name
- Medical ultrasnoic couplant EUDAMED
- Device Name
- Medical ultrasnoic couplant EUDAMED
- Model / Reference
- 12g、15g、20g、30g、50g、60g、80g、100g、120g、150g、200g、250g、300g、500g、1kg、2.5kg、5kg、10kg、20kg,or customized EUDAMED20g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970088600192 EUDAMED
- Basic UDI-DI
- 697008860MUcouplant67 EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I 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
Medical ultrasnoic couplant by Shandong jiabaitong Medical Technology 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 | 697008860MUcouplant67 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong jiabaitong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000052850
- Authorised Representative
- AION CIRCUITS, LDA PT-AR-000044689
Sources (1)
- EUDAMED 504186f2-698f-425d-a43a-fad6706d2c9d 61 fields · synced Oct 6, 2026