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Manual Wheelchair SIVFH2A102

by Jiangsu Pinkang Medical Technology Co., Ltd.

Ref FH2A102Model FH2A102, FH1A101, FH2A101, K2, H008, K7, Y105, TC04, EC02, DS02, DS03

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975650550028 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697565055WH5 Basic UDI-DI 06975650550028UDI-DIDate3 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Manual Wheelchair
Generic Name
Push-rim manual wheelchair, non-bariatric
Model / Reference
FH2A102 EUDAMED
FH1A101 EUDAMED
FH2A101 EUDAMED
K2 EUDAMED
H008 EUDAMED
K7 EUDAMED
Y105 EUDAMED
TC04 EUDAMED
EC02 EUDAMED
DS02 EUDAMED
DS03 EUDAMED
SIVFH2A102 GUDID
Primary DI / UDI-DI
06975650550028
Basic UDI-DI
697565055WH5
510(k) Number
FDA Product Code
IOR
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Push-rim manual wheelchair, non-bariatric
Device Class
Class I
Regulation Number
890.3850
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FH2A102, FH1A101, FH2A101, K2, H008, K7, Y105, TC04, EC02, DS02, DS03
FH2A102
GUDID
SIVFH2A102
Contains LatexEUDAMED
No
GUDID
Yes

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

Properties

  • Contains Latex NoEUDAMEDYesGUDID
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No