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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

Handpiece for ThermoStapler… — Class IIb MDR

MD Atlas
EMED SP. Z O. O. SP. K.

EUDAMED last updated this device on Aug 21, 2024

Handpiece for ThermoStapler Alpha® instrument, SDS cable 4m, reusable, non-sterile

59077632-TF15BIP-INSTR-UY

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EMED SP. Z O. O. SP. K.
UDI-DI code: 05907763264524
Reference / catalog number: 804-100

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View device family (Basic UDI)

Manufacturer information

Organization name: EMED SP. Z O. O. SP. K.
SRN: PL-MF-000012648
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0034/4919/2025Supplemented
Quality management systemNotified body: 2274Expiry: May 5, 2028

Critical warnings

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

CW011
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Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: Handpiece for ThermoStapler Alpha® instrument, SDS cable 4m, reusable, non-sterile
UDI-DI code: 05907763264524
Basic UDI-DI: 59077632-TF15BIP-INSTR-UY
Reference / catalog number: 804-100
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: For tissue fusion in bipolar electrosurgery in ThermoStapler® mode and mechanical cutting.
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)05907763264524

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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.

L180102ENDOSCOPIC ELECTROSURGERY DISSECTORS, REUSABLE

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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