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Organization name
UDI-DI code
Reference / catalog number

NLF-1000-000 — Class IIa MDR by Positrigo AG

MD Atlas
Positrigo AG

EUDAMED last updated this device on Nov 12, 2025

NLF-1000-000

7649998522NeuroLFME

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Positrigo AG
UDI-DI code: 07649998522038
Reference / catalog number: NLF-1000-000

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Manufacturer information

Organization name: Positrigo AG
SRN: CH-MF-000018932
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Read the instruction for use prior to use

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Nov 1, 2025	Still on market
Italy	Dec 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07649998522038
Basic UDI-DI: 7649998522NeuroLFME
Reference / catalog number: NLF-1000-000
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11020401POSITRON EMISSION TOMOGRAPHS

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

Related devices

NLF-1000-20007649998522NeuroLFMEOn the market NLF-1000-10007649998522NeuroLFMEOn the market NLF-3000-01007649998522NeuroLFSeatHGOn the market

Certificates

Certificate health across this manufacturer's portfolio.

G10 109044 0004Issued
Quality management systemNotified body: 0123Expiry: Oct 1, 2029