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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

TS 613 — Class I MDR by T.H. SERVICE SRL

MD Atlas
T.H. SERVICE SRL

EUDAMED last updated this device on Aug 12, 2025

TS 613

805620146TSSR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: T.H. SERVICE SRL
UDI-DI code: 08056201463870
Reference / catalog number: TS 613

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View device family (Basic UDI)

Manufacturer information

Organization name: T.H. SERVICE SRL
SRN: IT-MF-000028023
Manufacturer status: Active

Related devices

TS 512805620146TSSROn the market TS 513805620146TSSROn the market CA 008805620146CAQ2On the market CA 009805620146CAQ2On the market CA 023805620146CAQ2On 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

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08056201463870
Basic UDI-DI: 805620146TSSR
Reference / catalog number: TS 613
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: 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)08056201463870

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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.

T020199SURGICAL DRAPES - OTHER

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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