Pentax Medical Water Bottle Cap
by Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Ref 306349, 306347
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697090085101888 | Date17 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Clean Connecting Tubes
- Model / Reference
- 306349, 306347
- Primary DI / UDI-DI
- 06970900856967, 06936603218327
- Basic UDI-DI
- 697090085101888
- Direct Marketing DI
- 0697090085696706936603218327
- EMDN Code
- G0280 Gastrointestinal tubes - accessories
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009371
- Authorised representative
- Prolinx GmbH DE-AR-000005129
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Properties
Other properties (12)
- 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