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SPO2 Sensors
EUDAMEDClass IIb (EU MDR)
Ref U403S-01Ref AN543-01Model A403S-01Ref AF543-01XRef N543-1Ref AF523-01XRef U303-01Ref AF543-01Ref A410-01Ref A403-01Ref AF503-01Ref A103S-01Ref AF533-01
Identity
- Trade Name
- SPO2 Sensors EUDAMED
- Device Name
- SPO2 Sensors EUDAMED
- Model / Reference
- U403S-01 EUDAMEDA403S-01 EUDAMEDAN543-01 EUDAMEDAF543-01X EUDAMEDN543-1 EUDAMEDAF523-01X EUDAMEDU303-01 EUDAMEDAF543-01 EUDAMEDA410-01 EUDAMEDA403-01 EUDAMEDAF503-01 EUDAMEDA103S-01 EUDAMEDAF533-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394501972 EUDAMED06927394501446 EUDAMED06927394501309 EUDAMED06927394501958 EUDAMED06927394501323 EUDAMED06927394501965 EUDAMED06927394501293 EUDAMED06927394501187 EUDAMED06927394501170 EUDAMED06927394501279 EUDAMED06927394501026 EUDAMED06927394501347 EUDAMED06927394501019 EUDAMED
- Basic UDI-DI
- B-06927394501972 EUDAMED69273945SS01XK EUDAMEDB-06927394501958 EUDAMEDB-06927394501965 EUDAMED
- Direct Marketing DI
- 06927394501446 EUDAMED06927394501309 EUDAMED06927394501323 EUDAMED06927394501293 EUDAMED06927394501187 EUDAMED06927394501170 EUDAMED06927394501279 EUDAMED06927394501026 EUDAMED06927394501347 EUDAMED06927394501019 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SPO2 Sensors by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06927394501972 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06927394501972 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (13)
- EUDAMED 91f4cf75-1639-429d-8a4a-c7b5c0da750d 61 fields · synced Oct 6, 2026
- EUDAMED eb5c5992-5afd-4957-bf15-a5a05674a0a2 61 fields · synced May 16, 2026
- EUDAMED eaae01db-dd62-4038-8256-806bc40b64fa 61 fields · synced May 17, 2026
- EUDAMED d16d753d-fc78-4377-8f67-abf7d058d93c 61 fields · synced May 17, 2026
- EUDAMED 8c1b5902-5930-489f-836e-d4113483f8cb 61 fields · synced May 17, 2026
- EUDAMED 92638c9a-afc9-44c8-b623-fefa02184435 61 fields · synced May 17, 2026
- EUDAMED 309b4c7a-b271-4c90-9bf5-2a34c5c52961 61 fields · synced May 18, 2026
- EUDAMED 95154114-8421-479c-b0ff-3487224c3451 61 fields · synced May 18, 2026
- EUDAMED 49666b4b-4193-4fd6-80d7-54d107f0ad0a 61 fields · synced May 18, 2026
- EUDAMED 2e72a2ff-25f5-482a-ba97-8ecad4142e18 61 fields · synced May 18, 2026
- EUDAMED 34af6529-1d43-4a1f-82de-12e0bfcef41d 61 fields · synced May 18, 2026
- EUDAMED 464410a9-93e5-4f64-a37d-ecee8ec53648 61 fields · synced May 19, 2026
- EUDAMED 2138fcd9-823d-47f8-b4af-75130db22872 61 fields · synced May 19, 2026