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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

3388 — Class I MDR by MADESPA, S.A.

MD Atlas
MADESPA, S.A.

EUDAMED last updated this device on May 12, 2026

3388

84353161DM014A79

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MADESPA, S.A.
UDI-DI code: 08435316133883
Reference / catalog number: 3388

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Manufacturer information

Organization name: MADESPA, S.A.
SRN: ES-MF-000003915
Manufacturer status: Active

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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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Nov 8, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435316133883
Basic UDI-DI: 84353161DM014A79
Reference / catalog number: 3388
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: https://www.madespa.com/web/image/16878?unique=eefdd8d9bb6b7fbe50ca54dd0a6c175abbac739b
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020104DENTAL IMPRESSION SILICONES

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