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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

ColdZyme — Class III MDR by Enzymatica AB

MD Atlas
Enzymatica AB

EUDAMED last updated this device on Feb 25, 2025

ColdZyme

73400311CZMSJE

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Enzymatica AB
UDI-DI code: 07340031106016
Reference / catalog number: 101101

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View device family (Basic UDI)

Manufacturer information

Organization name: Enzymatica AB
SRN: SE-MF-000002254
Manufacturer status: Active

Related devices

10101073400311CZMSJEOn the market ColdZyme73400311CZMSJEOn the market 10111573400311CZMSJEOn the market 101010B-101010KEOn the market ColdZyme73400311CZMSJEOn the market

Certificates

Certificate health across this manufacturer's portfolio.

EPT 0477.MDR.24/5405Issued
Technical documentationNotified body: 0477Expiry: Mar 6, 2029
EPT 0477.MDR.24/5406Issued
Quality management systemNotified body: 0477Expiry: Mar 6, 2029

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement	Sep 1, 2024	Mar 6, 2029
XI	Sep 1, 2024	Mar 6, 2029

Device identification

Trade name: ColdZyme
UDI-DI code: 07340031106016
Basic UDI-DI: 73400311CZMSJE
Reference / catalog number: 101101
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Mouth spray - Treat and alleviate common cold and flu-like symtoms.
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)07340031106016

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UDI-PI DataMatrix

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

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EMDN nomenclature code(s)

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

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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