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
- 311S EUDAMEDFDA UDI
- Description
- Protective Coverlets for Mammography - 29.2cm x 33.0cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815137021251 EUDAMEDFDA UDI
- Basic UDI-DI
- 00815137021251BA EUDAMED
- Unit of Use DI
- 10815137021258 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 | 00815137021251BA | 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 be63eb43-9fff-4bdb-9429-a887ad7bc3a6 61 fields · synced Jun 18, 2026
- FDA UDI 8f99c17c-473f-4f67-ae89-fdb56702ca5e 34 fields · synced May 30, 2026