Identity
- Device Name
- PBS (10x) EUDAMED
- Model / Reference
- 44592 EUDAMED50374 EUDAMED44962 EUDAMED12016873 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287145922 EUDAMED08012992503744 EUDAMED08435287111682 EUDAMED08435287112085 EUDAMED
- Basic UDI-DI
- 8435287153PBS0000000ER EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) 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
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
PBS (10x) by Biosystems 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 | 8435287153PBS0000000ER | Class A | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED cc5afaed-bc92-405e-acb6-a50338c93650 61 fields · synced Aug 3, 2026
- EUDAMED e1390179-e5fa-4b73-8615-6b6dc285e324 61 fields · synced May 17, 2026
- EUDAMED 3461a5f6-9bed-4ad9-96cd-ad13da72d5a8 61 fields · synced May 17, 2026
- EUDAMED 8149977d-60f4-4faf-9a93-5289b1e1e164 61 fields · synced May 19, 2026