Precisor EXL

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 000389Ref 00389BRef 000384Ref 000388Ref 000385Ref 000386

by Conmed Corporation

Identity

Trade Name: Precisor EXL EUDAMEDFDA UDI
Generic Name: Flexible endoscopic biopsy forceps, single-use FDA UDI
Device Name: Non-orthopedic, Non-active, Instrument, Endoscopic, Biopsy Forceps EUDAMED
Precisor EXL Coated Disposable Biopsy Forceps, Alligator Cup with Needle, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup, 2.3 mm X 230 cm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup with Needle, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup with Needle, 160 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Alligator Cup, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Model / Reference: 000389 EUDAMEDFDA UDI
00389B EUDAMEDFDA UDI
000384 EUDAMEDFDA UDI
000388 EUDAMEDFDA UDI
000385 EUDAMEDFDA UDI
000386 EUDAMEDFDA UDI
Description: Precisor EXL Coated Disposable Biopsy Forceps, Alligator Cup with Needle, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup, 2.3 mm X 230 cm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup with Needle, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup, 230 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Oval Cup with Needle, 160 cm X 2.3 mm X 2.8 mm FDA UDI
Precisor EXL Coated Disposable Biopsy Forceps, Alligator Cup, 230 cm X 2.3 mm X 2.8 mm FDA UDI

Identifiers

Catalog Number: 000386 FDA UDI
00389B FDA UDI
000388 FDA UDI
000389 FDA UDI
000384 FDA UDI
000385 FDA UDI
Primary DI / UDI-DI: 30653405051880 EUDAMEDFDA UDI
10653405063858 EUDAMEDFDA UDI
30653405051842 EUDAMEDFDA UDI
30653405051873 EUDAMEDFDA UDI
30653405051859 EUDAMEDFDA UDI
30653405051866 EUDAMEDFDA UDI
Basic UDI-DI: B-30653405051880 EUDAMED
B-10653405063858 EUDAMED
B-30653405051842 EUDAMED
B-30653405051873 EUDAMED
B-30653405051859 EUDAMED
B-30653405051866 EUDAMED
FDA Product Code: FCL FDA UDI
EMDN Code: G0308010101 GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE EUDAMED
GMDN Term: Flexible endoscopic biopsy forceps, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 876.1075 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Width — 2.3 Millimeter FDA UDI
Length — 230 Centimeter FDA UDI
Outer Diameter — 2.8 Millimeter FDA UDI
Length — 160 Centimeter FDA UDI
Depth — 2.8 Millimeter FDA UDI

Category: Flexible endoscopic biopsy forceps, single-use

Precisor EXL by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible endoscopic biopsy forceps, single-use.

Disposable Biopsy Forceps — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class IIa
Single Use Biopsy Forceps — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class I
Disposable Endoscopic Biopsy Forceps — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
POWER-ENDO — Jiangsu Power-endo Medical Technology Co., Ltd · Class IIa
Single Use Biopsy Forceps — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Single-use Biopsy Forceps — Anrei Medical (HZ) CO., LTD. · Class IIa
Disposable Biopsy Forceps — Jiangsu Ate Medical Technology Co., Ltd. · Class IIa
Disposable Biopsy Forceps — Endoaccess GmbH · Class IIa

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-30653405051880	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Conmed Corporation
EUDAMED SRN: US-MF-000012663
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (17)

EUDAMED dc8aae64-f472-49d6-afd8-ffcd94d61850 61 fields · synced Jul 27, 2026
EUDAMED 87bc9149-1768-4bb0-8c91-f88cfb8b2cc6 61 fields · synced May 17, 2026
EUDAMED 7e0a759a-9f64-45d2-8b1a-3ce14a38f316 61 fields · synced May 17, 2026
EUDAMED e03bc92a-e007-4b5a-a30b-018f9fa5ab1b 61 fields · synced May 17, 2026
EUDAMED 4e479d30-3217-40a5-be70-ee372a030945 61 fields · synced May 17, 2026
EUDAMED 53a08813-a340-4873-b171-cb5d4eba5825 61 fields · synced May 18, 2026
FDA UDI 0ab7aba6-61a6-413b-8c53-d2e6e26ac3a7 36 fields · synced May 29, 2026
FDA UDI 0ea60ea6-7165-4ff4-9d26-a608767d5ecb 36 fields · synced May 29, 2026
FDA UDI 7661f5bf-2e8d-46e7-82d2-df3650ff4658 36 fields · synced May 30, 2026
FDA UDI 70067de8-22cc-4a3b-bb98-b5c316dd692b 36 fields · synced May 30, 2026
FDA UDI 905a86b2-1e8c-45f1-ac93-49ffaa9bc6b1 36 fields · synced May 30, 2026
FDA UDI a1f8dee0-075a-466d-9947-dcbbd4e5166e 36 fields · synced May 30, 2026
EUDAMED ec3a1b26-aaf5-4655-b331-ffda0f1cfd9a 61 fields · synced Jul 9, 2026
EUDAMED e1cc6bce-0f8e-4fc3-949f-5267ea2968b1 61 fields · synced Jul 10, 2026
EUDAMED 2ae74016-f9b7-4cef-9002-433f0cc0e6f5 61 fields · synced Jul 13, 2026
EUDAMED 9821e481-0d98-4cd0-944f-1daa8bc45f09 61 fields · synced Jul 21, 2026
EUDAMED 972b7069-5ff2-479f-9a23-1b87e9637032 61 fields · synced Jul 27, 2026