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AmpSure Sample Preservation Solution
EUDAMEDClass A (EU MDR)
Ref SPS2-20mL25CEModel SPS2Ref SPS2-3mL48CE
Identity
- Device Name
- AmpSure Sample Preservation Solution EUDAMED
- Model / Reference
- SPS2 EUDAMEDSPS2-20mL25CE EUDAMEDSPS2-3mL48CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737220960 EUDAMED06974737220229 EUDAMED
- Basic UDI-DI
- 697473722SPSSWABHH EUDAMED
- EMDN Code
- W0104010204 SAMPLE TRANSPORT FOR NA TESTING EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
AmpSure Sample Preservation Solution by Shanghai Rendu Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697473722SPSSWABHH | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai Rendu Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018869
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e78363e8-809b-4a60-a6fb-67fb1a3c422c 61 fields · synced Jul 31, 2026
- EUDAMED cc511b2c-4294-4d50-ab6a-1635bf7b94f4 61 fields · synced May 18, 2026