Skip to content

Reloading Unit for Linear Stapler (FLSL)H3.5E

by B. J. ZH. F. Panther Medical Equipment Co., Ltd.

Ref (FLSL)H3.5E

Reloading Unit for Linear Stapler (FLSL)H3.5E is a device classified as Class IIb in the EU and Class II in the US made by B. J. ZH. F. Panther Medical Equipment Co., Ltd., registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI B-06939282439175) and listed in FDA GUDID since 4 Apr 2018 (UDI-DI 06939282439175), active as of 22 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-06939282439175 Basic UDI-DI 06939282439175UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06939282439175 UDI-DI Date4 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06939282439175 registered 9 Jun 2026 Active
  • FDA GUDID UDI-DI 06939282439175 listed 4 Apr 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06939282439175
  2. Registered EUDAMED B-06939282439175

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PANTHER Reloading Unit for Linear Stapler EUDAMED
Reloading Unit for Linear Stapler GUDID
Generic name
Open-surgery manual linear stapler, single-use
Model / reference
(FLSL)H3.5E
Primary DI / UDI-DI
06939282439175
Basic UDI-DI
B-06939282439175
FDA product code
GDW
EMDN code
H0202010302 Single-patient linear suture cartdriges without blade for open surgery
GMDN term
Open-surgery manual linear stapler, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 06939282439175: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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: Open-surgery manual linear stapler, single-use

Similar devices in this category

Other devices filed under SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITHOUT BLADE FOR OPEN SURGERY.

Other devices from B.j.zh.f.panther Medical Equipment Co., Ltd

See all devices from B.j.zh.f.panther Medical Equipment Co., Ltd →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)