EUDAMED last updated this device on Jul 17, 2026

Amzyme 3 Manual

506072225AAA0003JN

On the marketClass I

Applicable legislation: —
Organization name: Amity Limited
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 →: 05060722251581
Reference / catalog number: J48AM

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.

Amzyme 3 Manual is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Amity Limited. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Amzyme 3 Manual
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 →: 05060722251581
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 →: 506072225AAA0003JN
Reference / catalog number: J48AM
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)05060722251581

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.

D0801ENZYMATIC DETERGENTS FOR MEDICAL DEVICES

Critical warnings

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

GHS05 -Danger or Warning -Corrosive cat. 1
GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards
H317 – May cause an allergic skin reaction.
H318 – Causes serious eye damage.
P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
P280 – Wear protective gloves/protective clothing/eye protection/face protection.
P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
OTHER
P310 - Immediately call a POISON CENTER
OTHER
P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	—	Still on market

Amzyme 3 Manual

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 covering this device

Related devices

Certificates