Oral/Enteral Syringe with ENfit
by Ningbo Tianyi Medical Appliance Co., Ltd. United States EUDAMED
Ref TY-6 OEN
EMDN A020108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number694515574000HS | Date4 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Oral/Enteral Syringe with ENfit
- Model / Reference
- TY-6 OEN
- Primary DI / UDI-DI
- 06945155743041
- Basic UDI-DI
- 694515574000HS
- Direct Marketing DI
- 06945155743041
- EMDN Code
- A020108 Enteral feeding syringes
- Device Class
- Class IIa
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000029875
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED cb2b36b4-d8af-4d57-946f-f6e1e99cdf6e