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Orthopedic Splint

by Jiangsu Senolo Medical Technology Co., Ltd. 11 variants

Model XB1,XB2,XB3,XB4,XB5,XB6,XB212,XB224,XB312,XB316,XB320,XB324,XB328,XB336,XB416,XB418,XB420,XB428,XB430,XB436,XB528,XB530,XB536,XB545,XB546,XB548,XB630,XB636,XB646,XB648

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69525344SPLINT200XV Basic UDI-DI 16952534421039UDI-DIDate13 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number16952534421039 UDI-DI Date6 Apr 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Senolo
Generic Name
First aid limb splint, non-mouldable, single-use
Device Name
Orthopedic Splint
Model / Reference
XB1, XB2, XB3, XB4, XB5, XB6, XB212, XB224, XB312, XB316, XB320, XB324, XB328, XB336, XB416, XB418, XB420, XB428, XB430, XB436, XB528, XB530, XB536, XB545, XB546, XB548, XB630, XB636, XB646, XB648
Primary DI / UDI-DI
16952534421039
Basic UDI-DI
69525344SPLINT200XV
FDA Product Code
HSP
EMDN Code
M03050202 Synthetic cast bandages and splints
GMDN Term
First aid limb splint, non-mouldable, single-use
Device Class
Class I
Regulation Number
888.5890
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000008281
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Senolo Medical Technology Co., Ltd.

See all devices from Jiangsu Senolo Medical Technology Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No