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Nest Nivr-11

by Wuxi Nest Biotechnology Co., Ltd. China EUDAMEDGUDID

Ref NIVR-11

Product code FMFEMDN A020203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697312286NIVRNL Basic UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941854803178 UDI-DIDate18 Sep 2025ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • 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
Pen Injector EUDAMED
Nest GUDID
Generic Name
Prefilled self-injector, multiple-dose
Model / Ref / Catalog
NIVR-11, BR80623, SR80623
Primary DI / UDI-DI
06941854803178, 06941854803185
Basic UDI-DI
697312286NIVRNL
Direct Marketing DI
06941854803185
06941854803178
510(k) Number
FDA Product Code
FMF
EMDN Code
A020203 Cartridge syringes
GMDN Term
Prefilled self-injector, multiple-dose
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
880.5860
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Prefilled self-injector, multiple-dose

Cleared under the same submission (K240774)

Show all (10)

Similar devices

Also classified as Prefilled self-injector, multiple-dose.

Other devices from Wuxi Nest Biotechnology Co., Ltd.

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Properties & raw data

Show properties, registry sources and raw records
  • Administering Medicine
  • Measuring Function
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (4)

  • FDA UDI afd10794-be20-4a7a-b756-95fe536b12a2 34 fields · synced 22 Oct 2026
  • FDA UDI c0a9c8b2-5ce6-48e4-8676-6b3fcac67a92 34 fields · synced 30 May 2026
  • EUDAMED 06941854803185|697312286NIVRNL 61 fields · synced 13 Jul 2026
  • EUDAMED 06941854803178|697312286NIVRNL 61 fields · synced 6 Oct 2026