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EUDAMED last updated this device on May 17, 2026
B-06945934602101Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →HK-A06-M OPP single bag is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Changzhou Huankang Medical Device Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →06945934602101Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →B-06945934602101HK-A06-M OPP single bagUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →(01)06945934602101
European Medical Device Nomenclature — the EU product classification assigned to this device.
U089006VAGINAL SPECULUM, SINGLE-USE1 warning recorded — scroll inside the panel to see all entries.
CW009Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | Still on market |
CN-MF-000009030No 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.DD 60149774 0001326012944B-06945934601982On the marketHK-A06-XS OPP INVISIOB-06945934604877On the marketHK-A06-M CARTON INVISIOB-16945934604850On the marketHK-A05-M carton OPP Medplus 100pcs/cartonB-16945934605901On the marketHK-A06-M carton OPP Medplus 150pcs/cartonB-26945934601993On the marketHK-A04-M carton OPP GLSMED 100pcs/cartonB-16945934603358On the market