Identity
- Trade Name
- Pulse Oximeter Probe EUDAMED
- Device Name
- Pulse Oximeter Probe EUDAMED
- Model / Reference
- ESA0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040101338 EUDAMED
- Basic UDI-DI
- 69450401ESA0008AB EUDAMED
- Direct Marketing DI
- 06945040101338 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Category: Pulse oximeter probe, single-use
Pulse Oximeter Probe by Contec Medical Systems Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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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 | 69450401ESA0008AB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED a4906201-198a-4dc6-9e89-a6630e054b9d 61 fields · synced Jun 18, 2026