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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

EpiHeart Transplant Holder — Class I MDR by EpiHeart Oy

MD Atlas
EpiHeart Oy

EUDAMED last updated this device on Oct 3, 2022

EpiHeart Transplant Holder

6429810632TRAHOL017E

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EpiHeart Oy
UDI-DI code: 06429810632111
Reference / catalog number: 64-000-002

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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: EpiHeart Transplant Holder
UDI-DI code: 06429810632111
Basic UDI-DI: 6429810632TRAHOL017E
Reference / catalog number: 64-000-002
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)

V0499CLINICAL USE CONTAINERS (NON-IVD) - OTHER

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 62-000-0026429810632OPESTA0186On 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.