nasal aspirator
by Zhongshan Sunneo Medical Instruments Co., Ltd.
Ref 1.0Model 1.0,2.0,3.0,3.0a,3.0b,3.0c,3.0d,3.0e,3.0f,Z1-1,Z1-2,Z1-3,Z2-1,Z2-2,Z2-3,Z1pro-1,Z1pro-2,Z1pro-3,Z2-1,Z2-2,Z2-3,Z3-1,Z3-2,Z3-3,X1-1,X1-2,X1-3,X1-4,X1-5,EN-10-1,EN-10-2,EN-10-3,EN-11-1,EN-11-2,EN-11-3,EN-12-1,EN-12-2,EN-12-3, etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697830501nasalaspiratorB5 06978305010007 | Date26 Feb 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- nasal aspirator
- Model / Reference
- 1.0, 2.0, 3.0, 3.0a, 3.0b, 3.0c, 3.0d, 3.0e, 3.0f, Z1-1, Z1-2, Z1-3, Z2-1, Z2-2, Z2-3, Z1pro-1, Z1pro-2, Z1pro-3, Z3-1, Z3-2, Z3-3, X1-1, X1-2, X1-3, X1-4, X1-5, EN-10-1, EN-10-2, EN-10-3, EN-11-1, EN-11-2, EN-11-3, EN-12-1, EN-12-2, EN-12-3, etc
- Primary DI / UDI-DI
- 06978305010007
- Basic UDI-DI
- 697830501nasalaspiratorB5
- EMDN Code
- Q030199 Nasopharyngeal devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039352
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhongshan Sunneo Medical Instruments Co Ltd
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No