PCR tube and plate
by Suzhou Acumen Biomedical Technology Co., LTD. China EUDAMED
Ref 260001 EMDN W050301029099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number6978704662600G9 | Date2 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- PCR tube and plate
- Model / Reference
- 260001
- Primary DI / UDI-DI
- 06978704661282
- Basic UDI-DI
- 6978704662600G9
- EMDN Code
- W050301029099 Samples analyses, plastic containers - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000038603
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 56e5e91f-8fad-4bb7-877e-95536ab8208e