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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

SP006-0022 — Class I MDR by C-RAD Positioning AB

MD Atlas
C-RAD Positioning AB

EUDAMED last updated this device on Dec 15, 2022

SP006-0022

735000528HITED

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: C-RAD Positioning AB
UDI-DI code: 17350005280496
Reference / catalog number: SP006-0022

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View device family (Basic UDI)

Manufacturer information

Organization name: C-RAD Positioning AB
SRN: SE-MF-000022326
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW013
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 17350005280496
Basic UDI-DI: 735000528HITED
Reference / catalog number: SP006-0022
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: https://www.c-rad.com/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)17350005280496

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z119010LASER SYSTEMS FOR PATIENT POSITIONING

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

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Certificates

Certificate health across this manufacturer's portfolio.

G10 002633 0007Issued
Quality management systemNotified body: 0123Expiry: Nov 13, 2028