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Fingertip Pulse Oximeters
EUDAMEDClass IIa (EU MDR)
Ref XM-113Ref XM-111Ref XM-112
Identity
- Trade Name
- Fingertip Pulse Oximeters EUDAMED
- Device Name
- Fingertip Pulse Oximeters EUDAMED
- Model / Reference
- XM-113 EUDAMEDXM-111 EUDAMEDXM-112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392215365 EUDAMED06970392215334 EUDAMED06970392215341 EUDAMED
- Basic UDI-DI
- 6970392211XM000287 EUDAMED
- Direct Marketing DI
- 06970392215365 EUDAMED06970392215334 EUDAMED06970392215341 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Fingertip Pulse Oximeters by Joytech Healthcare Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970392211XM000287 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 92731dcf-0b52-466d-8b39-5f6eeb1df23f 61 fields · synced Sep 17, 2026
- EUDAMED eae19490-c99d-4fc6-a303-0e0547a2ea74 61 fields · synced May 17, 2026
- EUDAMED a3d8ae12-03ca-40b6-849a-da34a5019c34 61 fields · synced May 18, 2026