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Biopsy Starter Kit 7385

by Protek Medical Products, Inc.

Ref 1-535-7385

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084191215000STNE Basic UDI-DI 00841912103652UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841912103652 UDI-DI Date16 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
aspen surgical® EUDAMED
Biopsy Starter Kit GUDID
Generic Name
Body-surface ultrasound imaging transducer cover
Device Name
Needle Guides (sterile)
Model / Reference
1-535-7385 EUDAMED
7385 GUDID
Primary DI / UDI-DI
00841912103652
Basic UDI-DI
084191215000STNE
EMDN Code
A018002 Needle guides
GMDN Term
Body-surface ultrasound imaging transducer cover
Device Class
Class I
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
High-level Disinfectant

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1-535-7385
GUDID
7385
SterileEUDAMED
Yes
GUDID
No

Related devices

Category: Needle guide, single-useUltrasound imaging system tracking positioner, reusableBody-surface ultrasound imaging transducer cover

Other devices from Protek Medical Products, Inc.

See all devices from Protek Medical Products, Inc. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Single Use: 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No