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Nest Nivr-05

by Wuxi Nest Biotechnology Co., Ltd. China EUDAMEDGUDID

Ref NIVR-05

Product code FMFEMDN A020203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06941854803116 UDI-DIDate18 Sep 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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 America
  • Listed
  • Not covered

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-05, BR80213, SR80213
Primary DI / UDI-DI
06941854803116, 06941854803123
Basic UDI-DI
697312286NIVRNL
Direct Marketing DI
06941854803116
06941854803123
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

Cleared under the same submission (K240774)

Show all (10)

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 4a50885b-3b53-4ced-88ae-4ef050e1bd7d 34 fields · synced 22 Oct 2026
  • FDA UDI 6646b56f-fc5c-452c-8098-33d7ae1947da 34 fields · synced 30 May 2026
  • EUDAMED 06941854803116|697312286NIVRNL 61 fields · synced 26 Jul 2026
  • EUDAMED 06941854803123|697312286NIVRNL 61 fields · synced 6 Oct 2026