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EUDAMED last updated this device on Mar 24, 2026
805414149PADELLAECPolypropylene sterilizable bed pan individually wrapped in COMED® pouch is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SYNTESYS S.R.L.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000027856(01)08054141492967
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
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 France; available across 1 country total.
Placed on the market in France; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08054141492967Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805414149PADELLAEC16 200 21UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
08054141492967× 1 unitBase unit18054141492964× 20 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
V0812FECES AND URINE COLLECTION AIDS (BED PANS AND PARROTS)Y091299DEJECTION DEVICES - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
805414149URINALES5On the marketPolyethylene men's urinal, 1000ml, with cap, in bag, with customized label805414149URINALES5On the marketPolyethylene women's urinal 1000 ml individually wrapped805414149URINALES5On the marketPolypropylene sterilizable bed pan individually wrapped with inserted cover805414149PADELLAECOn the marketPolypropylene sterilizable bed pan individually wrapped with inserted cover in COMED pouch805414149PADELLAECOn the marketSterile "Sekur Tainer" PP 120 ml urine container yellow screw cap collection device individually wrappedB-08054141490109On the marketNo 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.