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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

100000125 — Class I MDR by Merivaara Corporation

MD Atlas
Merivaara Corporation

EUDAMED last updated this device on Sep 26, 2024

100000125

64384350581S8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Merivaara Corporation
UDI-DI code: 06438435001257
Reference / catalog number: 100000125

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Manufacturer information

Organization name: Merivaara Corporation
SRN: FI-MF-000001175
Manufacturer status: Active

Related devices

10000012064384350581S8On the market 1000110436438435OTA0009S2On the market 100011043U6438435OTA0009S2On the market 1000001116438435OTA0008RYOn the market 1000103566438435OTA0009S2On 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
See IFU for warnings, cautions and notes

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: 06438435001257
Basic UDI-DI: 64384350581S8
Reference / catalog number: 100000125
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)

Z12011280PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES

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
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Software identification