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單一註冊編號(SRN)
在EUDAMED中註冊時分配給經濟運營商（製造商、授權代表、進口商）的唯一識別符。根據EU MDR，SRN必須出現在器材標籤上。
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
Track regulatory signals related to 單一註冊編號(SRN) across 27 authorities in real time.
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