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VeriEcto

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref A006-12030Model Type AL, Type AP, Type AZ510(k) K261196Ref CBN-1913Model Type BN-MAR-1;Type BN-MAR-2;Type BN-MAR-3;Type BN-MAR-4Ref CBN-1713Ref ABN2-1820Model Type X;Type CRef SBN-1810CRef ABN2-1410CRef SBN-1816Ref ABN2-1210CRef SBN-1810Ref CBN-1307Ref ABN2-2020Ref ABN2-1810C

by Promisemed Hangzhou Meditech Co., Ltd.

Identity

Trade Name
VeriEcto EUDAMED
Device Name
Multipurpose Drainage Catheters EUDAMED
Co-Axial biopsy devices EUDAMED
Disposable Automatic Biopsy Needle EUDAMED
Semi-Automatic Biopsy Needles EUDAMED
Model / Reference
Type AL, Type AP, Type AZ EUDAMED
A006-12030 EUDAMED
Type BN-MAR-1;Type BN-MAR-2;Type BN-MAR-3;Type BN-MAR-4 EUDAMED
CBN-1913 EUDAMED
CBN-1713 EUDAMED
Type X;Type C EUDAMED
ABN2-1820 EUDAMED
SBN-1810C EUDAMED
ABN2-1410C EUDAMED
SBN-1816 EUDAMED
ABN2-1210C EUDAMED
SBN-1810 EUDAMED
CBN-1307 EUDAMED
ABN2-2020 EUDAMED
ABN2-1810C EUDAMED

Identifiers

Primary DI / UDI-DI
06978111926226 EUDAMED
06978111923164 EUDAMED
06975965295034 EUDAMED
06975965295744 EUDAMED
06975965294877 EUDAMED
06975965295737 EUDAMED
06975965294808 EUDAMED
06978111924116 EUDAMED
06975965294792 EUDAMED
06975965296062 EUDAMED
06978111924635 EUDAMED
06975965295768 EUDAMED
Basic UDI-DI
697122740DCKAF9 EUDAMED
697122740CBNMR EUDAMED
697122740ABNMF EUDAMED
697122740SBNQ9 EUDAMED
510(k) Number
K261196 FDA 510(k)
FDA Product Code
KNW FDA 510(k)
EMDN Code
A060201 EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) EUDAMED
A0102010102 SHEARING BIOPSY GUNS EUDAMED
A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Market of Registration
Netherlands EUDAMED
Denmark EUDAMED
Sweden EUDAMED
Spain EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

VeriEcto by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.
EUDAMED SRN
CN-MF-000008465
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (13)

  • EUDAMED 119573ec-a36d-4f47-b715-2004c5134197 61 fields · synced Oct 6, 2026
  • FDA 510(k) K261196 24 fields · synced May 29, 2026
  • EUDAMED 74ebb9d1-7089-4a63-b494-5cccf5c61a9d 61 fields · synced Jul 9, 2026
  • EUDAMED 11987ab3-faa3-4f50-bbbd-555c223a595a 61 fields · synced Jul 9, 2026
  • EUDAMED 0521a51b-dfcf-458b-89ad-79062012a95f 61 fields · synced Jul 9, 2026
  • EUDAMED 70cc1b12-b5ab-4e58-ade1-23ed89bee27c 61 fields · synced Jul 10, 2026
  • EUDAMED 111c0f18-9d94-4ca1-b29a-8a604771df52 61 fields · synced Jul 15, 2026
  • EUDAMED 1303af09-8329-4984-afbc-659c77849e65 61 fields · synced Jul 17, 2026
  • EUDAMED 156c21be-58a3-42f2-b21e-3073759a8217 61 fields · synced Jul 18, 2026
  • EUDAMED a08b559c-a1b1-4ae4-91b6-242955e8ea00 61 fields · synced Jul 21, 2026
  • EUDAMED 443e50ac-bc18-4617-b44e-c0d491053d4d 61 fields · synced Aug 1, 2026
  • EUDAMED 65323ed8-7bd8-4cf1-938a-e9323c0ad8de 61 fields · synced Aug 2, 2026
  • EUDAMED ab9cdbf0-ebd6-4b61-9ebf-025c405ac5e5 61 fields · synced Aug 4, 2026