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LEM Suction LEM with bands

by Sapi Med SpA

Ref A.5650.3Model LEM

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED Number803363880LEMASPDJ Basic UDI-DI 08033638802328UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033638802328 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Lem
Generic Name
Haemorrhoid ligator
Device Name
Ligator
Model / Ref / Catalog
LEM, A.5650.3, Suction LEM with bands
Primary DI / UDI-DI
08033638802328
Basic UDI-DI
803363880LEMASPDJ, B-08033638802328
510(k) Number
FDA Product Code
FHN
EMDN Code
G020401 Haemorrhoid ligature sets
GMDN Term
Haemorrhoid ligator
Device Class
Class IIa 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
LEM
A.5650.3
GUDID
Suction LEM with bands
Device ClassEUDAMED
Class IIa
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
  • Contains Latex
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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