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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

MAD-003938M-HS12 — IVDD — Annex II List B IVDD by VITRO, S.A.

MD Atlas
VITRO, S.A.

EUDAMED last updated this device on Nov 23, 2021

MAD-003938M-HS12

B-08435421223103

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: VITRO, S.A.
UDI-DI code: 08435421223103
Reference / catalog number: MAD-003938M-HS12

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Manufacturer information

Organization name: VITRO, S.A.
SRN: ES-MF-000001498
Manufacturer status: Active

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MAD-001560QVSBC8435421200488YLOn the market MAD-001560QVS8435421200488YLOn the market MAD-001560Q8435421200488YLOn the market MAD-004071R/D8435421200473Y7On the market MAD-108.250M8435421200516XYOn 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
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08435421223103
Basic UDI-DI: B-08435421223103
Reference / catalog number: MAD-003938M-HS12
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: -
Additional information URL: https://www.vitro.bio/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105070501STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification