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ABX Difftrol
EUDAMEDClass B (EU MDR)
Ref 1300136019Model 2062207Ref 1300136015Ref 2062203Ref 2062208
Identity
- Trade Name
- ABX Difftrol EUDAMED
- Device Name
- ABX Difftrol EUDAMED
- Model / Reference
- 2062207 EUDAMED1300136019 EUDAMED1300136015 EUDAMED2062203 EUDAMED2062208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009703 EUDAMED03610230009697 EUDAMED03610230008553 EUDAMED03610230008560 EUDAMED03610230008546 EUDAMED
- Basic UDI-DI
- 361023difftrolXR EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ABX Difftrol by Horiba Abx Sas — Class B — 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 | 361023difftrolXR | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (5)
- EUDAMED 8205f012-e4f6-4035-98bc-2c9ec6711100 61 fields · synced Aug 3, 2026
- EUDAMED 03af638e-ff20-460a-a4c8-b6b1e0941e7a 61 fields · synced May 18, 2026
- EUDAMED c822b7e4-c971-4527-a6bc-a51582130b72 61 fields · synced May 18, 2026
- EUDAMED a83f8177-9b59-4804-9264-e71cb52c23a2 61 fields · synced May 19, 2026
- EUDAMED cd963cad-09df-4d9e-b69a-97e3fc8b437b 61 fields · synced May 19, 2026