← Back to catalogue
Infrared Thermometer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HW-1Ref HW-E01Ref HW-E03Ref HW-E04
Identity
- Trade Name
- Infrared Thermometer EUDAMEDSIMZO FDA UDI
- Generic Name
- Infrared patient thermometer, ear/skin FDA UDI
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- HW-1 EUDAMEDFDA UDIHW-E01 EUDAMEDFDA UDIHW-E03 EUDAMEDHW-E04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989101007 EUDAMED06959989101014 EUDAMED06959989101038 EUDAMED06959989101045 EUDAMED00810021171173 FDA UDI00810021171180 FDA UDI
- Basic UDI-DI
- 69599891XZEIR0001MP EUDAMED
- Direct Marketing DI
- 06959989101007 EUDAMED06959989101014 EUDAMED06959989101038 EUDAMED06959989101045 EUDAMED
- 510(k) Number
- K211583 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Infrared patient thermometer, ear/skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Infrared Thermometer by Dongguan SIMZO Electronic Technology Co., 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 | 69599891XZEIR0001MP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (6)
- EUDAMED b7a45577-3f8d-4cec-8481-664c7843b194 61 fields · synced Jul 14, 2026
- EUDAMED abbf877d-e507-42ba-a192-15d1aeebf502 61 fields · synced May 17, 2026
- EUDAMED a963c901-6e1a-4c5c-8e5e-c501af5a309a 61 fields · synced May 18, 2026
- FDA UDI 60cdfafe-ab13-4fbd-81f0-0617fb41b4d1 33 fields · synced May 30, 2026
- FDA UDI 684b1217-afa8-46bd-9075-85c0ffcd2c6e 33 fields · synced May 30, 2026
- EUDAMED 170f9134-0e1d-44de-8e02-85290d7fdcb4 61 fields · synced Jul 13, 2026