Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10340-000

by Erbe Elektromedizin GmbH

Identity

Trade Name: ERBE ESM 2 EUDAMED
ERBE FDA UDI
Generic Name: Surgical irrigation/aspiration pump, reusable FDA UDI
Device Name: ESM 2 suction module EUDAMED
ERBE ESM 2 suction module FDA UDI
Model / Reference: 10340-000 EUDAMEDFDA UDI
Description: ERBE ESM 2 suction module FDA UDI

Identifiers

Catalog Number: 10340-000 FDA UDI
Primary DI / UDI-DI: 04050147000322 EUDAMEDFDA UDI
Basic UDI-DI: 4050147ESM-2-DC EUDAMED
Direct Marketing DI: 04050147000322 EUDAMED
510(k) Number: K072404 FDA UDI
K231023 FDA UDI
FDA Product Code: FQH FDA UDI
EMDN Code: Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
GMDN Term: Surgical irrigation/aspiration pump, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.5475 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation/aspiration pump, reusable

Erbe by Erbe Elektromedizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration pump, reusable.

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CUFF:INFLATION FOR ROSI — VASCULAR TECHNOLOGY INCORPORATED · Class II
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POWER SUPPLY: ASSEMBLY FOR ROSI — VASCULAR TECHNOLOGY INCORPORATED · Class II
Riptide™ — Micro Therapeutics, Inc. · Class II
Tech Medical Services — TECH MEDICAL SERVICES, INC. · Class I
CORE — Stryker Corp. · Class II

Cleared under the same submission

K072404 also covers:

K231023 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Erbe Elektromedizin GmbH

Sources (2)

FDA UDI 6caa9a13-953f-489b-add5-9450188abc55 37 fields · synced Jul 9, 2026
EUDAMED 767ea08d-7041-4186-b066-99611a5bbd71 61 fields · synced Jul 9, 2026