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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

57268-HEL — Class I MDR by GE Healthcare Finland Oy

MD Atlas
GE Healthcare Finland Oy

EUDAMED last updated this device on Mar 26, 2025

57268-HEL

08406821BUG005817K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GE Healthcare Finland Oy
UDI-DI code: 00840682103633
Reference / catalog number: 57268-HEL

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Manufacturer information

Organization name: GE Healthcare Finland Oy
SRN: FI-MF-000001176
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW027
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 00840682103633
Basic UDI-DI: 08406821BUG005817K
Reference / catalog number: 57268-HEL
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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)

Z1203020285MULTI-PARAMETER MONITORS - CONSUMABLES

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

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1004-836-24Supplemented
Quality management systemNotified body: 0537Expiry: Feb 8, 2027