← Back to catalogue
Althea Xl
EUDAMEDClass A (EU MDR)
Ref 3801055Model ALTHEA XL Automatic Coagulometer Analyzer
Identity
- Trade Name
- ALTHEA XL EUDAMED
- Device Name
- ALTHEA XL EUDAMED
- Model / Reference
- ALTHEA XL Automatic Coagulometer Analyzer EUDAMED3801055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8435287390308 EUDAMED
- Basic UDI-DI
- 843528739030HC EUDAMED
- Direct Marketing DI
- 8435287390308 EUDAMED
- EMDN Code
- W0202020102 AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Althea Xl by Linear Chemicals S.L.U — 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 | 843528739030HC | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Linear Chemicals S.L.U
- EUDAMED SRN
- ES-MF-000003284
Sources (1)
- EUDAMED 5d7f3ac4-ab38-4853-a00d-d16a0a9e0d5a 61 fields · synced Jun 19, 2026