Identity
- Trade Name
- Aware Breast Self Exam EUDAMEDAware Breast Self-Exam Pad FDA UDI
- Generic Name
- Breast self-examination pad FDA UDI
- Device Name
- AWARE Breast Self Exam Pad EUDAMEDThe Aware™ Pad is intended to be used as an aid for performing breast self-examination. FDA UDI
- Model / Reference
- 1203 EUDAMEDFDA UDI
- Description
- The Aware™ Pad is intended to be used as an aid for performing breast self-examination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00083059012033 EUDAMEDFDA UDI
- Basic UDI-DI
- 000830591203XM EUDAMED
- 510(k) Number
- K991469 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Breast self-examination pad FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Aware Breast Self Exam by Biomerica, Inc. — Class I — 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 | 000830591203XM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e1c75a02-0ba6-4ba2-be7c-dd6a2e770fa5 61 fields · synced May 30, 2026
- FDA UDI b1a0029a-3526-4067-bfae-b6700b21013b 35 fields · synced May 30, 2026