- Role
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- Date of registration
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EUDAMED last updated this device on Dec 5, 2025
890612217PEW7QUBIX-Polyethylene and PowerFiber is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Qubix Medicare Private Limited. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IN-MF-000042759(01)08906122172613
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.
Indicates the need for the user to consult the instructions for use.
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 Germany; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Netherlands | — | Still on market |
| Slovenia | — | 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.
08906122172613Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
890612217PEW7QN-7006-PEUDI 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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
H0102010299SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - 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 →Certificate health across this manufacturer's portfolio.
2026-MDR/TD-036IssuedNotified 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.
2026-MDR/QS-034IssuedNotified 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.
2026-MDR/TD-034IssuedNotified 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.
2025-MDR/TD-079/AAmendedNotified 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.
2025-MDR/QS-079/AAmendedNotified 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.
2026-MDR/TD-035IssuedNotified 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 →890612217PEW7On the marketQUBIX-Polyethylene and PowerFiber890612217PEW7On the marketQUBIX-Polyethylene and PowerFiber890612217PEW7On the marketQUBIX-POLYGLACTIN890612217ABSK7On the marketQUBIX-POLYGLACTIN890612217ABSK7On the marketQUBIX-POLYGLACTIN890612217ABSK7On the marketNo certificate specifically references this device's Basic UDI-DI.