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Line Sources

by Radnostix, Inc. 13 variants

Part of a family of 12 devices: see the family page

Ref BM83-12XL

Line Sources (BM83-12XL) is a Class I device made by Radnostix, Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 0085002047LINEMH), active as of 8 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0085002047LINEMH Basic UDI-DI 00850020470754UDI-DIDate7 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Line Sources
Model / reference
BM83-12XL
Primary DI / UDI-DI
00850020470754
Basic UDI-DI
0085002047LINEMH
EMDN code
V9099 Various devices not included in other classes - other
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000009369
Authorised representative
CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Radnostix, Inc.

See all devices from Radnostix, Inc. →

Properties

Other properties (14, all answered No)