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Nasal Irrigator
EUDAMEDClass I (EU MDR)
Ref NI-001Model NI-001/NI-002/NI-003/NI-004
Identity
- Device Name
- Nasal Irrigator EUDAMED
- Model / Reference
- NI-001/NI-002/NI-003/NI-004 EUDAMEDNI-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974910980018 EUDAMED
- Basic UDI-DI
- 697491098BLDNIQ3 EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS 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
Category: Endoscopic spray catheter, single-use
Nasal Irrigator by Shenzhen Balinda Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic spray catheter, single-use.
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- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
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 | 697491098BLDNIQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Balinda Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000008857
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED afad7172-4ef0-40b3-812d-f2c6009bb1db 61 fields · synced Jul 14, 2026