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Nasal Hemostasis Sponge

by Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. 14 variants

Ref NS007Model E-type, N-type

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16975560670042 UDI-DI Date20 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697556067NS5M Basic UDI-DI 16975560670042UDI-DIDate8 Jul 2024RegisteredStatusActive

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  • Withdrawn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

Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
Model / Reference
E-type EUDAMED
N-type EUDAMED
NS007 EUDAMED
E4 GUDID
Primary DI / UDI-DI
16975560670042
Basic UDI-DI
697556067NS5M
FDA Product Code
LYA
EMDN Code
M040501 Polysaccharide haemostatic dressings
GMDN Term
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
Device Class
Class I
Regulation Number
874.4780
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
E-type, N-type
NS007
GUDID
E4

Manufacturer details

EUDAMED SRN
CN-MF-000038528
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd.

See all devices from Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Serial Number: No