Identity
- Trade Name
- Sixriver EUDAMED
- Device Name
- Nasal Strips Starter Kit EUDAMED
- Model / Reference
- JZA-BT-Ⅰ EUDAMED2026002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06980142590000 EUDAMED
- Basic UDI-DI
- 698014259000GG EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER 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
Category: Pulmonary function analysis system, adult
Sixriver by Zhejiang JOOZENA Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 698014259000GG | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang JOOZENA Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000055629
- Authorised Representative
- AION CIRCUITS, LDA PT-AR-000044689
Sources (1)
- EUDAMED 3a63fa29-f602-4fe9-a2d2-d23543c26911 61 fields · synced Jul 28, 2026