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Spunlance Surgical Gown, Standard

by Exact Medical Manufacturing, Inc 2 variants

Ref EU003150, EU003162, EU003152, 2105

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 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975085700753 UDI-DI Date3 Apr 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697508570SG04MV Basic UDI-DI Date30 Dec 2021RegisteredStatusActive

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 22 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  • Withdrawn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
Spunlance Surgical Gown, Standard EUDAMED
Exact Medical Manufacturing, Inc. GUDID
Generic Name
Surgical gown, single-use
Model / Ref / Catalog
EU003150, EU003162, EU003152, 2105
Primary DI / UDI-DI
06975085700753, 06975085700784, 06975085700760, 06975085709121
Basic UDI-DI
697508570SG04MV
510(k) Number
FDA Product Code
FYA
EMDN Code
T020401 Standard surgical gowns
GMDN Term
Surgical gown, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4040
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000001406
Authorised representative
Exact Medical Manufacturing B.V. NL-AR-000000452

Other devices from Exact Medical Manufacturing, Inc

See all devices from Exact Medical Manufacturing, Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No