Disposable Lightproof Infusion Sets
by Shandong Ande Healthcare Apparatus Co., Ltd. 43 variants
Ref A5014001EModel BGZ-S1
Disposable Lightproof Infusion Sets (A5014001E) is a Class IIa device made by Shandong Ande Healthcare Apparatus Co., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 697044002BGZ-S38M), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697044002BGZ-S38M 16941512139301 | Date6 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 697044002BGZ-S38M
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Disposable Lightproof Infusion Sets
- Model / reference
- BGZ-S1, A5014001E
- Primary DI / UDI-DI
- 16941512139301
- Basic UDI-DI
- 697044002BGZ-S38M
- EMDN code
- A03040199 Infusion kits (with or w/o pump), single-use - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011339
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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