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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

LetsGetChecked Blood Home Sample… — IVDR Class A IVDR

MD Atlas
PrivaPath Diagnostics Limited

EUDAMED last updated this device on Mar 27, 2026

LetsGetChecked Blood Home Sample Collection Kit

8600032112BO86

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PrivaPath Diagnostics Limited
UDI-DI code: 00860003211212
Reference / catalog number: BO08I

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View device family (Basic UDI)

Manufacturer information

Organization name: PrivaPath Diagnostics Limited
SRN: IE-MF-000045162
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.

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Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: LetsGetChecked Blood Home Sample Collection Kit
UDI-DI code: 00860003211212
Basic UDI-DI: 8600032112BO86
Reference / catalog number: BO08I
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The LetsGetChecked Blood Home Sample Collection Kit is an in vitro diagnostic medical device specifically intended for the containment and preservation of blood specimens for the purpose of in vitro diagnostic examination by our partner laboratories.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)00860003211212

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0501010299CAPILLARY BLOOD COLLECTION DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.