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EUDAMED last updated this device on May 13, 2026
69385355SurgicalbladeCRWE12 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Huaiyin Medical Instruments Co., Ltd. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0693853554329469385355SurgicalbladeCRWE12(01)06938535543294
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
V010302BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES1 warning recorded — scroll inside the panel to see all entries.
CW001No certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jun 1, 2024 | Still on market |
| France | Jan 1, 2021 | Still on market |
| Netherlands | Jan 1, 2023 | Still on market |
| Poland | Jan 1, 2023 | Still on market |
| Türkiye | Jan 1, 2023 | Still on market |
CN-MF-000003351No 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.