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PCR (Polymerase Chain Reaction) Amplifying Apparatus
EUDAMEDClass IVD General (EU MDR)
Ref L1699
Identity
- Trade Name
- PCR (Polymerase Chain Reaction) Amplifying Apparatus EUDAMED
- Device Name
- PCR (Polymerase Chain Reaction) Amplifying Apparatus EUDAMEDPCR (Polymerase Chain Reaction) Amplifying Apparatus EUDAMED
- Model / Reference
- L1699 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470032 EUDAMED
- Basic UDI-DI
- B-06975760470032 EUDAMED697576047CRS5RQ EUDAMED
- EMDN Code
- L1699 DIAGNOSTIC INSTRUMENTS, REUSABLE- OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
PCR (Polymerase Chain Reaction) Amplifying Apparatus by Suzhou Precigenome Ltd, Co; — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975760470032 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975760470032 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED b24ccfd6-1210-4ffd-ae7e-ece15d479e48 61 fields · synced Jun 19, 2026
- EUDAMED 6e144817-d811-4b8c-a4c4-00b3c00b121b 61 fields · synced May 17, 2026