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Sertilac 32300M20

by Peters Surgical

Ref 32300M20

Sertilac 32300M20 is a device classified as Class IIa in the EU and Class I in the US made by Peters Surgical, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-03661522000984) and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 03661522000984), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03661522000984 Basic UDI-DI 03661522000984UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661522000984 UDI-DI Date9 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03661522000984 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 03661522000984 listed 9 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03661522000984
  2. Registered EUDAMED B-03661522000984

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  • Withdrawn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
Sertilac® EUDAMED
Sertilac GUDID
Generic name
Surgical support tape, non-bioabsorbable
Model / reference
32300M20
Primary DI / UDI-DI
03661522000984
Basic UDI-DI
B-03661522000984
FDA product code
GAE
EMDN code
H900299 Tapes, medical/surgical - other
GMDN term
Surgical support tape, non-bioabsorbable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

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

Similar devices in this category

Other devices filed under TAPES, MEDICAL/SURGICAL - OTHER.

Other devices from Peters Surgical

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Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)