Identity
- Trade Name
- Micro+ EUDAMEDSmokerlyzer FDA UDI
- Generic Name
- Carbon monoxide breath analyser FDA UDI
- Device Name
- PiCO EUDAMEDThe Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment. FDA UDI
- Model / Reference
- Smokerlyzer EUDAMEDMICROADV EUDAMEDMicro+ FDA UDI
- Description
- The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment. FDA UDI
Identifiers
- Catalog Number
- MICROADV FDA UDI
- Primary DI / UDI-DI
- 05060246860047 EUDAMEDFDA UDI
- Basic UDI-DI
- 506024686SM017H EUDAMED
- Direct Marketing DI
- 05060246860047 EUDAMED
- 510(k) Number
- K082315 FDA UDI
- FDA Product Code
- CCJ FDA UDI
- EMDN Code
- Z1203020402 CARBON MONOXIDE ANALYSERS EUDAMED
- GMDN Term
- Carbon monoxide breath analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1430 FDA UDI
- Market of Registration
- Slovakia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Micro+ by Bedfont Scientific Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506024686SM017H | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bedfont Scientific Ltd
- EUDAMED SRN
- GB-MF-000010889
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9df0e71a-3d22-4242-afed-14c36dcc4fb0 61 fields · synced Jul 9, 2026
- FDA UDI 1688502e-6ae1-4937-ae95-c5a887aa7bcd 35 fields · synced May 29, 2026