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D50 Automatic Digital PCR System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 48031Model D50Ref 30171
Identity
- Trade Name
- D50 Automatic Digital PCR System EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- D50 Automatic Digital PCR System EUDAMED
- Model / Reference
- D50 EUDAMED48031 EUDAMED30171 EUDAMEDD50 Automatic Digital PCR System/D50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689625172 EUDAMEDFDA UDI
- Basic UDI-DI
- 0697468962517B9 EUDAMED697468962517SH EUDAMED
- FDA Product Code
- PHG FDA UDI
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
D50 Automatic Digital PCR System by TargetingOne Technology (Beijing) Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0697468962517B9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 20fe5de7-c0d8-4811-89ca-e2da06c88190 61 fields · synced Jun 18, 2026
- FDA UDI 168b22fa-0f8e-443a-9df8-06be82ead88b 32 fields · synced May 30, 2026
- EUDAMED 61b91837-98dc-4d1e-81d1-70955d60d3ab 61 fields · synced Jun 18, 2026