Super Sheath Introducer Sheath
by Togo Medikit Co., Ltd. 4 variants
Ref S-3W5/1007 (BT33Z05PGW018)
Super Sheath Introducer Sheath (S-3W5/1007 (BT33Z05PGW018)) is a Class IIa device made by Togo Medikit Co., Ltd., registered in EUDAMED on 27 Aug 2026 (Basic UDI-DI B-04543527199834), active as of 24 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04543527199834 04543527199834 | Date27 Aug 2026 | StatusActive |
Official records
- EUDAMED public site B-04543527199834
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- S-3W5/1007 (BT33Z05PGW018)
- Primary DI / UDI-DI
- 04543527199834
- Basic UDI-DI
- B-04543527199834
- EMDN code
- C0504 Arterial introduction sets
- Device class
- Class IIa
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000013805
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Similar devices in this category
Other devices filed under ARTERIAL INTRODUCTION SETS.
- RAILWAY Sheathless Access System RW5ADTB by Cordis US Corp.
- Super Sheath XL CI14L11TP0038 by TOGO MEDIKIT CO., LTD.
- Needle 195352 by Argon Medical Devices, Inc.
- Needle 195350 by Argon Medical Devices, Inc.
- Super Sheath BT60Z11PGW035 by TOGO MEDIKIT CO., LTD.
- REBOA™ Catheter Convenience Kit (EU) KT1835E by Prytime Medical Devices Inc.
- ARROW IPN922859 RA-04220-W by TELEFLEX INCORPORATED
- RAILWAY Sheathless Access System RW6ADTH by Cordis US Corp.