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PlexBio 100 Fluorescent Analyzer
EUDAMEDClass A (EU MDR)
Ref 80000-2Model PB100
Identity
- Trade Name
- PlexBio 100 Fluorescent Analyzer EUDAMED
- Device Name
- PlexBio 100 Fluorescent Analyzer EUDAMED
- Model / Reference
- PB100 EUDAMED80000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882810015 EUDAMED
- Basic UDI-DI
- 471988281MultiplexFAM3 EUDAMED
- Direct Marketing DI
- 04719882810015 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
PlexBio 100 Fluorescent Analyzer by PlexBio 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 | 471988281MultiplexFAM3 | Class A | Active |
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Manufacturer
- Manufacturer
- PlexBio Co., Ltd.
- EUDAMED SRN
- TW-MF-000031803
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 268304dc-62ae-4937-bc54-921ece0e01fd 61 fields · synced Jun 19, 2026