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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

62-000-002 — Class I MDR by EpiHeart Oy

MD Atlas
EpiHeart Oy

EUDAMED last updated this device on Oct 3, 2022

62-000-002

6429810632OPESTA0186

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EpiHeart Oy
UDI-DI code: 06429810632135
Reference / catalog number: 62-000-002

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Manufacturer information

Organization name: EpiHeart Oy
SRN: FI-MF-000018287
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement	Oct 2, 2022	Still on market
Germany	Oct 2, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429810632135
Basic UDI-DI: 6429810632OPESTA0186
Reference / catalog number: 62-000-002
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)

V0402CLINICAL USE TRAYS AND BOWLS

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

Related devices

EpiHeart Adapter for Centrifuge6429810632ADACEN01GZOn the market EpiHeart Catheter for supernatant removal6429810632CATSUP01ZMOn the market EpiHeart Transplant Holder6429810632TRAHOL017EOn 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.