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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

13221126 — Class IIa MDD by Berner Oy

MD Atlas
Berner Oy

EUDAMED last updated this device on Dec 17, 2021

13221126

B-06414500007058

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Berner Oy
UDI-DI code: 06414500007058
Reference / catalog number: 13221126

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Manufacturer information

Organization name: Berner Oy
SRN: FI-MF-000007402
Manufacturer status: Active

Related devices

13221142B-06414500007157On the market 13221122B-06414504294737On the market 13221132B-06414504139847On the market 13221124B-06414500007065On the market 13221326641450LR01ETOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW038
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 3 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Estonia		Still on market
Sweden		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06414500007058
Basic UDI-DI: B-06414500007058
Reference / catalog number: 13221126
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
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.

EMDN nomenclature code(s)

D0701ETHANOL FOR THE DISINFECTION OF MEDICAL DEVICES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification