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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

ORT-02030104 — Class I MDR by ORTOTECSA,S.L.

MD Atlas
ORTOTECSA,S.L.

EUDAMED last updated this device on May 12, 2026

ORT-02030104

843660217TMWJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTECSA,S.L.
UDI-DI code: 08436602174603
Reference / catalog number: ORT-02030104

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Manufacturer information

Organization name: ORTOTECSA,S.L.
SRN: ES-MF-000004786
Manufacturer status: Active

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T.P.1004843660217MOVZOn the market F.79843660217TRWUOn the market G.6770843660217ATV7On the market G.6760843660217ATV7On the market G.6750-BP843660217ATV7On 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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08436602174603
Basic UDI-DI: 843660217TMWJ
Reference / catalog number: ORT-02030104
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: BLUE/MEDIUM HANDBALL (GEL)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y0503HANDS AND FINGERS RE-EDUCATION DEVICES

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
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Software identification