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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

11001 — Class I MDR by Sanicen S.A.

MD Atlas
Sanicen S.A.

EUDAMED last updated this device on Apr 30, 2026

11001

8431026Gloves/N/SP/EXJT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sanicen S.A.
UDI-DI code: 08431026110015
Reference / catalog number: 11001

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Manufacturer information

Organization name: Sanicen S.A.
SRN: ES-MF-000000738
Manufacturer status: Active

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.

Market distribution

Primary placement in Spain; available across 3 countries total.

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

Device identification

Trade name: not provided
UDI-DI code: 08431026110015
Basic UDI-DI: 8431026Gloves/N/SP/EXJT
Reference / catalog number: 11001
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)

T01020204NITRILE EXAMINATION / TREATMENT GLOVES

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

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