Apk A1315-C11
Ref A1315-C11
Apk A1315-C11 is a device classified as Class I in the EU and Class II in the US made by APK Technology Co., Ltd., registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI 69467255A-SPO2-cableKJ) and listed in FDA GUDID since 22 Sep 2025 (UDI-DI 06946725544839), active as of 12 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69467255A-SPO2-cableKJ 06946725544839 | Date20 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06946725544839 | Date22 Sep 2025 | StatusListed |
Official records
- EUDAMED public site 69467255A-SPO2-cableKJ
- AccessGUDID record 06946725544839
Across registries
- EUDAMED Basic UDI-DI 69467255A-SPO2-cableKJ registered 20 Mar 2026 Active
- FDA GUDID UDI-DI 06946725544839 listed 22 Sep 2025 Listed
Timeline
- Listed FDA GUDID 06946725544839
- Registered EUDAMED 69467255A-SPO2-cableKJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- SpO2 Extension Cable EUDAMEDApk GUDID
- Generic name
- Electrical-only medical device connection cable, reusable
- Model / reference
- A1315-C11
- Primary DI / UDI-DI
- 06946725544839
- Basic UDI-DI
- 69467255A-SPO2-cableKJ
- FDA product code
- IKD
- EMDN code
- Z12030285 Vital signs monitoring instruments - consumables
- GMDN term
- Electrical-only medical device connection cable, reusable
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 890.1175
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
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