- Role
- Country
- Date of registration
- Address
CN-MF-000032692No 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.Reamer Head Φ11.5 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by WUHAN MINDRAY SCIENTIFIC CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-06934635737618Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)06934635737618
1 warning recorded — scroll inside the panel to see all entries.
The use of the device must be selected by a qualified orthopedic surgeon based on the patient's condition. Due to the wide variety of products for fixation of fractures, it is necessary to select the fracture internal fixation instruments according to ensure the correct operation.
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 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Sep 30, 2020 | Sep 30, 2070 |
| Austria | Sep 30, 2020 | Sep 30, 2070 |
| Belgium | Sep 30, 2020 | Sep 30, 2070 |
| Bulgaria | Sep 30, 2020 | Sep 30, 2070 |
| Cyprus | Sep 30, 2020 | Sep 30, 2070 |
| Czechia | Sep 30, 2020 | Sep 30, 2070 |
| Denmark | Sep 30, 2020 | Sep 30, 2070 |
| Estonia | Sep 30, 2020 | Sep 30, 2070 |
| EL | Sep 30, 2020 | Sep 30, 2070 |
| Spain | Sep 30, 2020 | Sep 30, 2070 |
| Finland | Sep 30, 2020 | Sep 30, 2070 |
| France | Sep 30, 2020 | Sep 30, 2070 |
| Croatia | Sep 30, 2020 | Sep 30, 2070 |
| Hungary | Sep 30, 2020 | Sep 30, 2070 |
| Ireland | Sep 30, 2020 | Sep 30, 2070 |
| Iceland | Sep 30, 2020 | Sep 30, 2070 |
| Italy | Sep 30, 2020 | Sep 30, 2070 |
| Liechtenstein | Sep 30, 2020 | Sep 30, 2070 |
| Lithuania | Sep 30, 2020 | Sep 30, 2070 |
| Luxembourg | Sep 30, 2020 | Sep 30, 2070 |
| Latvia | Sep 30, 2020 | Sep 30, 2070 |
| Malta | Sep 30, 2020 | Sep 30, 2070 |
| Netherlands | Sep 30, 2020 | Sep 30, 2070 |
| Norway | Sep 30, 2020 | Sep 30, 2070 |
| Poland | Sep 30, 2020 | Sep 30, 2070 |
| Portugal | Sep 30, 2020 | Sep 30, 2070 |
| Romania | Sep 30, 2020 | Sep 30, 2070 |
| Sweden | Sep 30, 2020 | Sep 30, 2070 |
| Slovenia | Sep 30, 2020 | Sep 30, 2070 |
| Slovakia | Sep 30, 2020 | Sep 30, 2070 |
| Türkiye | Sep 30, 2020 | Sep 30, 2070 |
| XI | Sep 30, 2020 | Sep 30, 2070 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06934635737618Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06934635737618F16BB-PA00071UDI 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.
L0916ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLENo certificate specifically references this device's Basic UDI-DI.