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单一注册编号(SRN)
在EUDAMED中注册时分配给经济运营商（制造商、授权代表、进口商）的唯一标识符。根据EU MDR，SRN必须出现在器械标签上。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
The Single Registration Number (SRN) identifies economic operators (manufacturers, authorized representatives, importers) in EUDAMED under EU MDR/IVDR.
PROCESS / STEPS
- Create an actor registration in EUDAMED (or national process while modules phase in).
- Obtain SRN and use it on declarations, labels/UDI interfaces, and vigilance communications as required.
- Keep actor data current when company names, addresses, or roles change.
EXAMPLES
- An EU importer must hold its own SRN separate from the non-EU manufacturer’s SRN.
RELATED GUIDES & TOOLS
SOURCES
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