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PL-MF-000012648Disposable smoke evacuation handle with knife electrode, 2 switches, cable 3m, 3-pin plug, sterile. is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by EMED SP. Z O. O. SP. K.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
59077632-TF19HANDLE-SE-XPPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05907763284461
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
See IFU
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Germany | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05907763284461Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
59077632-TF19HANDLE-SE-XP848-030UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
2 packaging levels registered — each level carries its own UDI-DI.
05907763284461× 1 unitBase unit05907763284492× 5 units05907763284508× 20 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
K0201010501OPEN ELECTROSURGERY HANDPIECES, SINGLE-USECertificate health across this manufacturer's portfolio.
TNP/MDR/0034/4919/2025SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
59077632-TF11NE-DISPO-MPOn the marketDisposable neutral electrode EMED SAFE, hydrogel, split, for infants, 181x76mm, 37cm259077632-TF11NE-DISPO-MPOn the marketDisposable neutral electrode EMED SAFE, hydrogel, split, for infants, 181x76mm, 37cm2, with 3m US cable59077632-TF11NE-DISPO-MPOn the marketElectrode handle 2.4mm, small, 2 switches, cable 3m, 3-pin plug59077632-TF19HANDLE-AYOn the marketElectrode handle 2.4mm, small, 2 switches, cable 3m, SDS plug59077632-TF19HANDLE-AYOn the marketElectrode handle 4mm, large, 2 switches, cable 4m, 3-pin plug59077632-TF19HANDLE-AYOn the market