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Real-Time PCR System
EUDAMEDClass A (EU MDR)
Ref H621105Model Pangaea 3fast/4fast/5fast/6fastRef H621103，H621104，H621105，H621106
Identity
- Device Name
- Real-Time PCR System EUDAMED
- Model / Reference
- Pangaea 3fast/4fast/5fast/6fast EUDAMEDH621105 EUDAMEDH621103，H621104，H621105，H621106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974149865117 EUDAMED06974149860112 EUDAMED06974149863113 EUDAMED
- Basic UDI-DI
- 69741498611YP EUDAMED
- Direct Marketing DI
- 06974149865117 EUDAMED06974149860112 EUDAMED06974149863113 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
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
No
EUDAMED
Real-Time PCR System by Aperbio Technologies (Suzhou) 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 | 69741498611YP | Class A | Active |
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Manufacturer
- Manufacturer
- Aperbio Technologies (Suzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000045149
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (3)
- EUDAMED e2a80061-73b6-4a12-bc3e-41a652c84ef4 61 fields · synced Jul 29, 2026
- EUDAMED 1fd313bf-60b5-4583-9951-fe72f2e062d4 61 fields · synced May 16, 2026
- EUDAMED d99abe81-03fd-42fe-8030-1b0982e07eba 61 fields · synced May 17, 2026