Oral/Enteral Syringe
by Ningbo Tianyi Medical Appliance Co., Ltd. 14 variants
Ref TY-20 BPEO
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number694515574001HU 06945155741429 | Date4 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number06945155741429 | Date20 Feb 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- ENFit oral/enteral syringe, single-use
- Device Name
- Oral/Enteral Syringe
- Model / Ref / Catalog
- TY-20 BPEO
- Primary DI / UDI-DI
- 06945155741429
- Basic UDI-DI
- 694515574001HU
- Direct Marketing DI
- 06945155741429
- FDA Product Code
- PNR
- EMDN Code
- A020108 Enteral feeding syringes
- GMDN Term
- ENFit oral/enteral syringe, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 876.5980
- EU market of registration
- Northern Ireland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000029875
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ningbo Tianyi Medical Appliance CO., Ltd.
See all devices from Ningbo Tianyi Medical Appliance CO., Ltd. →
Properties
Other properties (18)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- Premarket Exempt: No
- Serial Number: No