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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

101010 — Class III MDD by Enzymatica AB

MD Atlas
Enzymatica AB

EUDAMED last updated this device on May 30, 2024

101010

B-101010KE

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Enzymatica AB
UDI-DI code: D-101010KE
Reference / catalog number: 101010

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View device family (Basic UDI)

Manufacturer information

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

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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 Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-101010KE
Basic UDI-DI: B-101010KE
Reference / catalog number: 101010
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Mouthspray against common cold
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

D-101010KE

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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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