Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SPL-0001 — IVDD — General IVDD by SPOTLAB SL

MD Atlas
SPOTLAB SL

EUDAMED last updated this device on Sep 17, 2024

SPL-0001

B-ESMF000044194ADSYJ

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: SPOTLAB SL
UDI-DI code: D-ESMF000044194ADSYJ
Reference / catalog number: SPL-0001

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: SPOTLAB SL
SRN: ES-MF-000044194
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-ESMF000044194ADSYJ
Basic UDI-DI: B-ESMF000044194ADSYJ
Reference / catalog number: SPL-0001
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: AdaptaSpot Smart is an optical microscopy analysis system that supports the diagnostic process of biological samples under a microscope (including human, animal and plant origin samples) , posibiliting its digitization, analysis and reporting. It consists of a hardware device, mobile app, cloud platform and artificial intelligence algorithms.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02020199CELL COUNTING INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SPL-0002B-ESMF000044194TRS4WOn 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.