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Btl Spinal Decompression Premium

by BTL Industries Limited

Ref P096.101

Btl Spinal Decompression Premium (P096.101) is a medical device (EU MDR Class I; EMDN category treatment) made by BTL Industries Limited, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI ++B108496SDJK), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B108496SDJK Basic UDI-DI B108496SDPREMEU00UDI-DIDate3 Nov 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  • Withdrawn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
Btl Spinal Decompression
Model / reference
P096.101
Primary DI / UDI-DI
B108496SDPREMEU00
Basic UDI-DI
++B108496SDJK
Direct marketing DI
B108496SDPREMEU00
EMDN code
V080603 Treatment, diagnosis and monitoring medical beds
Device class
Class I
EU registration type
Standard device
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000034894
Authorised representative
BTL ITALIA S.r.l. IT-AR-000020508

Similar devices in this category

Other devices filed under TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS.

Other devices from BTL Industries Limited

See all devices from BTL Industries Limited →

Properties

Other properties (14, all answered No)