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tube sealer

by Changsha Yingtai Instrument Co., Ltd 18 variants

Part of a family of 18 devices: see the family page

Ref 085Model Iseal-100

tube sealer (085) is a blood donor bag tube divider/sealer (EU MDR Class I; FDA Class I; FDA product code KSD, Device, Heat-Sealing) made by Changsha Yingtai Instrument Co., Ltd, registered in EUDAMED on 18 Jul 2025 (Basic UDI-DI 697630191tubesealerBE) and listed in FDA GUDID since 30 Apr 2025 (UDI-DI 06976301910857), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697630191tubesealerBE Basic UDI-DI 06976301910857UDI-DIDate18 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06976301910857 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697630191tubesealerBE registered 18 Jul 2025 Active
  • FDA GUDID UDI-DI 06976301910857 listed 30 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06976301910857
  2. Registered EUDAMED 697630191tubesealerBE

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  • Withdrawn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
Yingtai
Generic name
Blood donor bag tube divider/sealer
Model / reference
Iseal-100 EUDAMED
085 EUDAMED
iSeal-140 GUDID
Primary DI / UDI-DI
06976301910857
Basic UDI-DI
697630191tubesealerBE
Direct marketing DI
06976301910857
FDA product code
KSD
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Blood donor bag tube divider/sealer
Device class
Class I
Regulation number
864.9750
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Iseal-100
085
GUDID
iSeal-140

Manufacturer details

EUDAMED SRN
CN-MF-000034851
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Similar devices in this category

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

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Properties

  • Reusable
  • Premarket exempt
  • Manufacturing date
Other properties (22, all answered No)