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Palm Shield

by Elastic Therapy

Ref 8563BEIUNR, 8563BEIUNL

Palm Shield (8563BEIUNR) is a Class I device made by Elastic Therapy, registered in EUDAMED on 25 Aug 2022 (Basic UDI-DI 7631898563D8), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7631898563D8 Basic UDI-DI Date25 Aug 2022RegisteredStatusActive

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  • Withdrawn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
Palm Shield
Model / reference
8563BEIUNR, 8563BEIUNL
Primary DI / UDI-DI
00885914037430, 00885914037423
Basic UDI-DI
7631898563D8
EMDN code
Y060603 Fingers orthoses
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000021563
Authorised representative
CEpartner4U NL-AR-000000111

Similar devices in this category

Other devices filed under FINGERS ORTHOSES.

Other devices from Elastic Therapy

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Properties

Other properties (14, all answered No)