EUDAMED last updated this device on Jul 14, 2026

ALPHAHYSTERO

4049047LBT01AGA27DREMB

On the marketClass I

Applicable legislation: —
Organization name: Gimmi GmbH
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04049047657422
Reference / catalog number: S.7042.01

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ALPHAHYSTERO is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Gimmi GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ALPHAHYSTERO
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04049047657422
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 4049047LBT01AGA27DREMB
Reference / catalog number: S.7042.01
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04049047657422

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L059099OBSTETRICS AND GYNECOLOGY INSTRUMENTS, REUSABLE - OTHER

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

Consult instructions for use
Caution

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 12 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Denmark	—	Still on market
EL	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Sweden	—	Still on market

Related searches

Class I medical devices in EUDAMED

Device identification

Trade name: ALPHAHYSTERO
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 04049047657422
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 4049047LBT01AGA27DREMB
Reference / catalog number: S.7042.01
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in Germany; available across 12 countries total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market
Austria	—	Still on market
Belgium	—	Still on market
Denmark	—	Still on market
EL	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Italy	—	Still on market
Poland	—	Still on market
Portugal	—	Still on market
Sweden	—	Still on market

ALPHAHYSTERO

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices

Certificates covering this device