Identity
- Trade Name
- Bella Blankets FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Bella Blankets EUDAMEDProtective Coverlets for Mammography - 29.2cm x 33.0cm FDA UDI
- Model / Reference
- 311 EUDAMEDFDA UDI
- Description
- Protective Coverlets for Mammography - 29.2cm x 33.0cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815137020247 EUDAMEDFDA UDI
- Basic UDI-DI
- 00815137020247BC EUDAMED
- Unit of Use DI
- 10815137020244 EUDAMED
- 510(k) Number
- K073262 FDA UDI
- FDA Product Code
- IZH FDA UDI
- EMDN Code
- T0210 NON-SURGICAL DRAPES EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1710 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Bella Blankets by Beekley Corporation — 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 | 00815137020247BC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-MF-000007055
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4d8c0345-b2e0-4cbd-9cff-99226418a544 61 fields · synced Aug 2, 2026
- FDA UDI 81e18f41-4d81-4d04-9d08-e6494d49d4f9 34 fields · synced May 30, 2026