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PIC THERMOEasy Plus
EUDAMEDClass IIa (EU MDR)
Ref 58010398000100Ref 58010398000000Ref 58010398000200
Identity
- Trade Name
- PIC THERMOEasy Plus EUDAMED
- Device Name
- Infrared Forehead Thermometer EUDAMED
- Model / Reference
- 58010398000100 EUDAMED58010398000000 EUDAMED58010398000200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392215112 EUDAMED06970392215228 EUDAMED06970392215136 EUDAMED
- Basic UDI-DI
- 6970392211ET000635 EUDAMED
- Direct Marketing DI
- 06970392215112 EUDAMED06970392215228 EUDAMED06970392215136 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
PIC THERMOEasy Plus 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 | 6970392211ET000635 | 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 838c50f7-d43f-4e8e-97dc-1f5aca246484 61 fields · synced Aug 3, 2026
- EUDAMED 2faf1d94-d6d0-4ffb-827b-6753f1d7b3f8 61 fields · synced May 18, 2026
- EUDAMED eedf6504-112b-498c-8394-9c43090e0728 61 fields · synced May 18, 2026