Closed System Transfer Devices for Single Use
by Shandong Ande Healthcare Apparatus Co., Ltd. 72 variants
Part of a family of 20 devices: see the family page
Ref DC1005Model CSTD-C0, CSTD-C5, CSTD-C10, CSTD-C30
Closed System Transfer Devices for Single Use (DC1005) is a Class I device made by Shandong Ande Healthcare Apparatus Co., Ltd., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 697044002WCSTD3JS), 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 | Number697044002WCSTD3JS 16941512120286 | Date21 May 2026 | StatusActive |
Official records
- EUDAMED public site 697044002WCSTD3JS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Closed System Transfer Devices for Single Use
- Model / reference
- CSTD-C0, CSTD-C5, CSTD-C10, CSTD-C30, DC1005
- Primary DI / UDI-DI
- 16941512120286
- Basic UDI-DI
- 697044002WCSTD3JS
- EMDN code
- A0704 Systems for reconstitution and administration of pharmaceuticals
- Device class
- Class I
- 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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