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Organization name
UDI-DI code
Reference / catalog number

Lifecare Dental SWE — Class I MDD by Tieto Finland Oy

MD Atlas
Tieto Finland Oy

EUDAMED last updated this device on Dec 15, 2021

Lifecare Dental SWE

B-06430076650061

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Tieto Finland Oy
UDI-DI code: 06430076650061
Reference / catalog number: 128481

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Manufacturer information

Organization name: Tieto Finland Oy
SRN: FI-MF-000002445
Manufacturer status: Active

Market distribution

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Device identification

Trade name: Lifecare Dental SWE
UDI-DI code: 06430076650061
Basic UDI-DI: B-06430076650061
Reference / catalog number: 128481
Issuing entity: GS1

Classification

Risk category: Class I
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)

V92MEDICAL DEVICE SOFTWARE - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1226-911-26Supplemented
Quality management systemNotified body: 0537Expiry: Aug 11, 2028