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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

LiLLY — Class IIa MDD by TSE spol. s r.o.

MD Atlas
TSE spol. s r.o.

EUDAMED last updated this device on May 29, 2026

LiLLY

B-08594216240036

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: TSE spol. s r.o.
UDI-DI code: 08594216240036
Reference / catalog number: 11FY95026G

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View device family (Basic UDI)

Manufacturer information

Organization name: TSE spol. s r.o.
SRN: CZ-MF-000026442
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Dec 31, 2028	Still on market

Device identification

Trade name: LiLLY
UDI-DI code: 08594216240036
Basic UDI-DI: B-08594216240036
Reference / catalog number: 11FY95026G
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08594216240036

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EMDN nomenclature code(s)

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

Z12080401PAEDIATRIC PHOTOTHERAPY EQUIPMENT

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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Related devices

INFANT PHOTOTHERAPEUTIC DEVICE859421624FTL-620JXOn the market NATALLYB-08594216240029On the market SHELLYB-08594216240005On the market 11FY95033GB-08594216240012On 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.