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ECO Disposable microwave therapeutic antenna ECO-100AI25

by ECO Medical Technology (Nanjing) Co., Ltd.

Ref ECO-100AI25

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06972405770441 Basic UDI-DI 06972405770441UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972405770441 UDI-DI Date2 Nov 2022ListedStatusListed GUDID: not in commercial distribution

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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Disposable Microwave Therapeutic Antennas EUDAMED
ECO Disposable microwave therapeutic antenna GUDID
Generic Name
Microwave ablation system probe, non-powered
Model / Reference
ECO-100AI25
Primary DI / UDI-DI
06972405770441 EUDAMED
06972405777211 GUDID
Basic UDI-DI
B-06972405770441
510(k) Number
FDA Product Code
NEY
EMDN Code
Z1204021580 Multi-district oncological therapy instruments (excluding radiotherapy) - hardware accessories
GMDN Term
Microwave ablation system probe, non-powered
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06972405770441
GUDID
06972405777211
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

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

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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