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Lactate Pro 2 Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 105882Ref 105883
Identity
- Trade Name
- Lactate Pro 2 Test Strip EUDAMED
- Device Name
- Lactate Pro 2 Test Strip EUDAMED
- Model / Reference
- 105882 EUDAMED105883 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-105882NB EUDAMEDD-105883ND EUDAMED
- Basic UDI-DI
- B-105882NB EUDAMEDB-105883ND EUDAMED
- EMDN Code
- W0101060104 LACTATE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Lithuania EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lactate Pro 2 Test Strip by ARKRAY Factory, Inc. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-105882NB | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (2)
- EUDAMED af379e40-690c-4d8a-a845-3248bf09bcce 61 fields · synced Jul 29, 2026
- EUDAMED 9f2c2ff4-894e-432e-8e36-8574435ad08d 61 fields · synced May 19, 2026