Non-Coring Needles
by Shandong Ande Healthcare Apparatus Co., Ltd. 130 variants
Part of a family of 109 devices: see the family page
Ref 01011925Model HN-01-A, HN-01-B, HN-02-B, HP-01-A, HP-01-B, HP-02-B
Non-Coring Needles (01011925) is a Class IIa device made by Shandong Ande Healthcare Apparatus Co., Ltd., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 697044002WZYZAQS), 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 | Number697044002WZYZAQS 16941512107898 | Date23 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 697044002WZYZAQS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Non-Coring Needles
- Model / reference
- HN-01-A, HN-01-B, HN-02-B, HP-01-A, HP-01-B, HP-02-B, 01011925
- Primary DI / UDI-DI
- 16941512107898
- Basic UDI-DI
- 697044002WZYZAQS
- EMDN code
- A01010302 Needles and kits for implantable systems (port), w/o safety systems
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011339
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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