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Berrcom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0DT007+1AR002Model DT007, DT008, DT113, DT116, DT117, DT119
Identity
- Trade Name
- BERRCOM EUDAMEDFDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DT007, DT008, DT113, DT116, DT117, DT119 EUDAMED0DT007+1AR002 EUDAMEDDT007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947656113262 EUDAMEDFDA UDI
- Basic UDI-DI
- 69476561DTXXX4R EUDAMED
- Direct Marketing DI
- 06947656113262 EUDAMED
- FDA Product Code
- FLL FDA UDISDV FDA UDI
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Cyprus 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Berrcom by Guangzhou Berrcom Medical Device 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 | 69476561DTXXX4R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Berrcom Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000013852
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2f2aa5bb-4c48-41fa-ba2d-55593d7459b1 61 fields · synced Jul 18, 2026
- FDA UDI f58d07f6-6e6e-4bf1-80a9-3aacfdec9808 32 fields · synced May 30, 2026