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AVALON BIOMED E20-E45/assorted/60pc

by Shanghai Xing Yu Medical Equipment Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06978880223625 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Avalon Biomed
Generic Name
Natural gutta-percha
Model / Reference
E20-E45/assorted/60pc
Primary DI / UDI-DI
06978880223625
FDA Product Code
EKM
GMDN Term
Natural gutta-percha
Device Class
Class I
Regulation Number
872.3850
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Shanghai Xing Yu Medical Equipment Co., Ltd.

See all devices from Shanghai Xing Yu Medical Equipment Co., Ltd. →

Properties

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

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No