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SINMARE Refill Pack
EUDAMEDClass I (EU MDR)
Ref NN-SS30Model SALINE: AX-SS30,NN-SS27,NN-SS23,NN-SS21,NN-XX12,NN-SS30 IRRIGATION: AX-KT250,NN-KT250E,NN-KT250D,NN-KT125,NN-KT500,NN-KT300
Identity
- Trade Name
- SINMARE Refill Pack EUDAMED
- Device Name
- solution saline EUDAMED
- Model / Reference
- SALINE: AX-SS30,NN-SS27,NN-SS23,NN-SS21,NN-XX12,NN-SS30 IRRIGATION: AX-KT250,NN-KT250E,NN-KT250D,NN-KT125,NN-KT500,NN-KT300 EUDAMEDNN-SS30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970082864972 EUDAMED
- Basic UDI-DI
- 697008286SO01KA EUDAMED
- Direct Marketing DI
- 06970082864972 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
SINMARE Refill Pack by Zhuhai Ninuo Biological 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 | 697008286SO01KA | Class I | Active |
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Manufacturer
- Manufacturer
- Zhuhai Ninuo Biological Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023308
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED f188e131-f31d-4c85-93bd-4bd8cd4042e7 61 fields · synced Jul 27, 2026