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The Edge
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref S5800024Ref S5638025Ref S54108, S54153, S54154, S54155, S54156, S54157, S54158
Identity
- Trade Name
- THE EDGE EUDAMED
- Device Name
- THE EDGE lactate control solution EUDAMEDTHE EDGE blood lactate test strips EUDAMEDTHE EDGE Blood Lactate Monitoring System EUDAMED
- Model / Reference
- S5800024 EUDAMEDS5638025 EUDAMEDS54108, S54153, S54154, S54155, S54156, S54157, S54158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487610ALSZP EUDAMEDD-47136487610ALTZR EUDAMEDD-47136487610A05K EUDAMED
- Basic UDI-DI
- B-47136487610ALSZP EUDAMEDB-47136487610ALTZR EUDAMEDB-47136487610A05K EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW0101060104 LACTATE TEST STRIPS EUDAMEDW0101060104,W010106010801,W0201069099 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
The Edge by Apex Biotechnology Corp. — 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-47136487610ALSZP | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 997beeec-a774-4cd5-8a85-70b6bdf56bb1 61 fields · synced Jul 23, 2026
- EUDAMED b772840a-d66a-4a58-b2ab-d43cb7751cd5 61 fields · synced May 17, 2026
- EUDAMED df2899b7-5f4a-4840-afea-683078f3bb18 61 fields · synced May 18, 2026
- EUDAMED df2899b7-5f4a-4840-afea-683078f3bb18-1 61 fields · synced Jul 12, 2026