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Super Sheath BT60Z11PGW035

by Togo Medikit Co., Ltd.

Ref H7493908614B1 (BT60Z11PGW035)

Super Sheath BT60Z11PGW035 is a device classified as Class IIa in the EU and Class II in the US made by Togo Medikit Co., Ltd., registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI B-04543527267113), cleared under FDA 510(k) K200379 on 19 Mar 2020 and listed in FDA GUDID since 13 Mar 2025 (UDI-DI 04543527267113), active as of 9 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200379

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04543527267113 Basic UDI-DI 04543527267113UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04543527267113 UDI-DI Date13 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK200379 Date19 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04543527267113 registered 8 Sep 2026 Active
  • FDA 510(k) K200379 decided 19 Mar 2020 Active
  • FDA GUDID UDI-DI 04543527267113 listed 13 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200379
  2. Listed FDA GUDID 04543527267113
  3. Registered EUDAMED B-04543527267113

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Super Sheath
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Super Sheath, Super Sheath R/O
Model / reference
H7493908614B1 (BT60Z11PGW035) EUDAMED
BT60Z11PGW035 GUDID
Primary DI / UDI-DI
04543527267113
Basic UDI-DI
B-04543527267113
510(k) Number
FDA product code
DRE, DYB
EMDN code
C0504 Arterial introduction sets
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1310, 870.1340
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
H7493908614B1 (BT60Z11PGW035)
GUDID
BT60Z11PGW035
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K200379)

and 8 more cleared under K200379

Similar devices in this category

Other devices filed under ARTERIAL INTRODUCTION SETS.

Other devices from Togo Medikit Co., Ltd.

See all devices from Togo Medikit Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)