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Insect Bite Healer
EUDAMEDClass IIa (EU MDR)
Ref BR100Model IB 100, IB 200, IB 150, IB 80, IB A50, IB 50E, IBR10, IBR20, IBR30, IBR40, IBR50, IBR60, IBR600, IBR700, IBR800, IBR900, BR70, BR75, BR100, BR200, IB 50E, IBR70, IBR75, IBR80
Identity
- Trade Name
- Insect Bite Healer EUDAMED
- Device Name
- Insect Bite Healer EUDAMED
- Model / Reference
- IB 100, IB 200, IB 150, IB 80, IB A50, IB 50E, IBR10, IBR20, IBR30, IBR40, IBR50, IBR60, IBR600, IBR700, IBR800, IBR900, BR70, BR75, BR100, BR200, IB 50E, IBR70, IBR75, IBR80 EUDAMEDBR100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976313751264 EUDAMED
- Basic UDI-DI
- 697631375IBXTG EUDAMED
- Direct Marketing DI
- 06976313751264 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Insect Bite Healer by AOJ HEALTH Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697631375IBXTG | Class IIa | Active |
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Manufacturer
- Manufacturer
- AOJ HEALTH Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000037449
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 89271288-bc98-4b7f-b67f-6117f06712b6 61 fields · synced Jun 18, 2026