Zaragatoa Oral Com Dentífrico
by Changzhou Newrise Medical & Hygiene Products Co., Ltd 2 variants
Ref NROS421Model 10cm, 10.5cm, 11cm, 12cm, 13cm, 13.5cm, 15cm, 15.5cm, 19cm
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 | Number697632566XROSWJ | Date21 Apr 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- Withdrawn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
- Oral Swab
- Model / Reference
- 10cm, 10.5cm, 11cm, 12cm, 13cm, 13.5cm, 15cm, 15.5cm, 19cm, NROS421
- Primary DI / UDI-DI
- 26976325664211, 16976325664214
- Basic UDI-DI
- 697632566XROSWJ
- Direct Marketing DI
- 2697632566421116976325664214
- EMDN Code
- A1101 Sample collection neutral swabs
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000013196
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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