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EUDAMED last updated this device on May 11, 2026
69317478SP000021NWUniversal Set Standard, PRIMARY PLUS is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697100478031869317478SP000021NW63702-00(01)06971004780318
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.
T0202SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)2 warnings recorded — scroll inside the panel to see all entries.
CW009CW007No certificate specifically references this device's Basic UDI-DI.
Primary placement in Belgium; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | Oct 14, 2019 | Dec 31, 2099 |
| Germany | Oct 14, 2019 | Dec 31, 2099 |
| Spain | Oct 14, 2019 | Dec 31, 2099 |
| France | Oct 14, 2019 | Dec 31, 2099 |
| XI | Oct 14, 2019 | Dec 31, 2099 |
CN-MF-000009427No 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.