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Nucleic Acid Releaser (For PCR)
EUDAMEDClass A (EU MDR)
Ref SR10100Model SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01
Identity
- Trade Name
- Nucleic Acid Releaser (For PCR) EUDAMED
- Device Name
- Nucleic Acid Releaser (For PCR) EUDAMED
- Model / Reference
- SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01 EUDAMEDSR10100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974081870507 EUDAMED
- Basic UDI-DI
- 697408187SR4D EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Nucleic Acid Releaser (For PCR) by Singuway Biotech Inc. — 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 | 697408187SR4D | Class A | Active |
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Manufacturer
- Manufacturer
- Singuway Biotech Inc.
- EUDAMED SRN
- CN-MF-000027180
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ebb08e00-8142-445f-bfe3-d4119673e3e0 61 fields · synced Jun 18, 2026