Identity
- Trade Name
- Digicen 21R EUDAMED
- Device Name
- Digicen 21 EUDAMED
- Model / Reference
- CE 110IVD EUDAMEDCE 113IVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436611980332 EUDAMED
- Basic UDI-DI
- 843661198-IVD-DIG1-BR EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Digicen 21R by Álvarez Redondo, S.A. — 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 | 843661198-IVD-DIG1-BR | Class A | Active |
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Manufacturer
- Manufacturer
- Álvarez Redondo, S.A.
- EUDAMED SRN
- ES-MF-000000560
Sources (1)
- EUDAMED 351e8f2d-74c7-4eca-8c2a-9959d5e4bf8d 61 fields · synced Jun 19, 2026