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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

EDTA TUBE DI-K 4ML PP — IVDR Class A IVDR by Deltalab, S.L.

MD Atlas
Deltalab, S.L.

EUDAMED last updated this device on May 25, 2026

EDTA TUBE DI-K 4ML PP

84356058UDI-DI-166D

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Deltalab, S.L.
UDI-DI code: 08435263850970
Reference / catalog number: 601402

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View device family (Basic UDI)

Manufacturer information

Organization name: Deltalab, S.L.
SRN: ES-MF-000000153
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

2024 PR 0038Issued
Quality assuranceNotified body: 0318Expiry: Oct 21, 2029

Critical warnings

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

CW010
Avoid extreme temperatures. Do not use it if the product has changed its original color. Do not use if dirtiness is visible. Do not use if expiry date is exceeded. Do not use if broken or with missing components. Disposal as biological waste.

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Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
France		Still on market

Device identification

Trade name: EDTA TUBE DI-K 4ML PP
UDI-DI code: 08435263850970
Basic UDI-DI: 84356058UDI-DI-166D
Reference / catalog number: 601402
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: 12
Additional product description: —
Additional information URL: https://www.deltalabgroup.com/eifus
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)08435263850970

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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.

W050101010201BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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