Identity
- Trade Name
- Nasal Saline Solution EUDAMED
- Device Name
- Nasal Saline Solution EUDAMED
- Model / Reference
- 10mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975998150188 EUDAMED
- Basic UDI-DI
- 697599815NSS4P EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS 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
Nasal Saline Solution by ANKIYA Bio Tec Co., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697599815NSS4P | Class I | Unknown |
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Manufacturer
- Manufacturer
- ANKIYA Bio Tec Co., LTD.
- EUDAMED SRN
- CN-MF-000032516
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4f365f0d-e1ad-449b-8160-48f07a0e7526 61 fields · synced Jun 18, 2026