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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

3646 — Class I MDR by MADESPA, S.A.

MD Atlas
MADESPA, S.A.

EUDAMED last updated this device on May 18, 2026

3646

84353161DM014A79

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MADESPA, S.A.
UDI-DI code: 08435316136464
Reference / catalog number: 3646

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Manufacturer information

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

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
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	Jun 18, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435316136464
Basic UDI-DI: 84353161DM014A79
Reference / catalog number: 3646
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)

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

Related devices

321284353161DM004064On the market 348384353161DM014A79On the market ID LIGHT BODY REGULAR 4x50 ml84353161DM014A79On the market 317684353161DM014A79On the market 316884353161DM014A79On 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.