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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

ALAYA Spine Dilator — Class IIa MDR by Cyber Surgery S.L.

MD Atlas
Cyber Surgery S.L.

EUDAMED last updated this device on Feb 17, 2026

ALAYA Spine Dilator

84370208470001IIAEUVT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cyber Surgery S.L.
UDI-DI code: 08437020847070
Reference / catalog number: SRAI-DIL

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Manufacturer information

Organization name: Cyber Surgery S.L.
SRN: ES-MF-000042958
Manufacturer status: Active

Related devices

ALAYA Spine A-B Tool Guide84370208470001IREUN2On the market ALAYA Spine Awl84370208470001IIAEUVTOn the market ALAYA Spine C Tool Guide84370208470001IREUN2On the market ALAYA Spine Drill Guide84370208470001IIAEUVTOn the market ALAYA Spine Fiducial84370208470001FIEUKYOn 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

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

CW010
EUDAMED did not publish a description for this code.
CW999
To be used only with ALAYA Spine Fiducial and ALAYA Spine Robotic Assistant.
CW999
Do not use with: -Patients under 18 and over 85 years of age. -Patients with obesity (considered as BMI of 30 or higher by the WHO). -Patients with severe scoliosis. -Patients with severe osteoporosis. -Pregnant or breastfeeding patients. -Patients with infection or neoplasm.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Oct 30, 2025	Still on market

Device identification

Trade name: ALAYA Spine Dilator
UDI-DI code: 08437020847070
Basic UDI-DI: 84370208470001IIAEUVT
Reference / catalog number: SRAI-DIL
Issuing entity: GS1

Classification

Risk category: Class IIa
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://cyber-surgery.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0919ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE

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

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Expiration date
Manufacturing date
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Software identification