Skip to content

Surefire

by Advance Medical Designs, Inc. United States EUDAMEDGUDID

Ref 28-TPH162 Product code ITXEMDN A018002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8483400028-TPH16236 Basic UDI-DIDate24 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340015045 UDI-DIDate18 Aug 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Surefire EUDAMED
Ultrasound Probe Cover Biopsy Needle Guide GUDID
Generic Name
Medical equipment handle cover, single-use
Device Name
Surefire Transperineal Guide 16G-18G
Model / Reference
28-TPH162 EUDAMED
28-EG162 GUDID
Primary DI / UDI-DI
00848340015045
Basic UDI-DI
8483400028-TPH16236
510(k) Number
FDA Product Code
ITX
EMDN Code
A018002 Needle guides
GMDN Term
Medical equipment handle cover, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1570
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
28-TPH162
GUDID
28-EG162
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
US-MF-000009790
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Advance Medical Designs, Inc.

See all devices from Advance Medical Designs, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Lot / Batch Number
  • Expiration Date
Other properties (20)
  • 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED ec98c280-1a28-4971-bb67-d9f8c91b5b5f 61 fields · synced 22 Oct 2026
  • FDA UDI c78b07ef-46f3-480f-a0d5-a489621c22d6 34 fields · synced 30 May 2026