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LEM Traction LEM with rind loader

by Sapi Med SpA

Ref A.5661Model Ligator

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 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803363880BNDLGTRKG Basic UDI-DI 08033638801673UDI-DIDate13 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638801673 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
Lem
Generic Name
Haemorrhoid ligator
Model / Ref / Catalog
Ligator, A.5661, Traction LEM with rind loader
Primary DI / UDI-DI
08033638801673
Basic UDI-DI
803363880BNDLGTRKG
510(k) Number
FDA Product Code
FHN
EMDN Code
G020401 Haemorrhoid ligature sets
GMDN Term
Haemorrhoid ligator
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.4400
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Ligator
A.5661
GUDID
Traction LEM with rind loader
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K070881)

Other devices from Sapi Med SpA

See all devices from Sapi Med SpA →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No