Anti-B Monoclonal

by Rapid Labs Ltd United Kingdom EUDAMED

Ref BG-B10Model Monoclonal EMDN W0103030101

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05060599400143GU Basic UDI-DI	Date22 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: Monoclonal, BG-B10

Primary DI / UDI-DI: D-05060599400143GU, 5060599400143XA
Basic UDI-DI: B-05060599400143GU, B-5060599400143XA
EMDN Code: W0103030101, W0103030102

Device Class: Class IVD Annex II List A
Market of Registration: Poland
Greece

Manufacturer details

EUDAMED SRN: GB-MF-000026335
Authorised representative: Advena Limited MT-AR-000000234

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (2)

EUDAMED a945656d-3d9d-4a14-a8e0-d8743bd98268 61 fields · synced 22 Oct 2026
EUDAMED 5060599400143XA|B-5060599400143XA 61 fields · synced 14 Oct 2026