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Blossom 3-Ply Earloop Facemask With Latex Free Elastic Blue
EUDAMEDFDA UDIClass I (EU MDR)
Ref FM-B1001Model 3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC
Identity
- Trade Name
- BLOSSOM 3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC BLUE EUDAMEDBLOSSOM FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- 3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC EUDAMED3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC BLUE FDA UDI
- Model / Reference
- 3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC EUDAMEDFM-B1001 EUDAMEDFDA UDI
- Description
- 3-PLY EARLOOP FACEMASK WITH LATEX FREE ELASTIC BLUE FDA UDI
Identifiers
- Catalog Number
- FM-B1001 FDA UDI
- Primary DI / UDI-DI
- 00723860110015 EUDAMEDFDA UDI
- Basic UDI-DI
- 0723860351778E EUDAMED
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blossom 3-Ply Earloop Facemask With Latex Free Elastic Blue by Mexpo International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0723860351778E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mexpo International, Inc.
- EUDAMED SRN
- US-MF-000032548
- Authorised Representative
- Blossom Europe, S.L. ES-AR-000019689
Sources (2)
- EUDAMED 0f5bcb06-ea39-412a-9bf7-0f3c00b94a63 61 fields · synced Jun 18, 2026
- FDA UDI 9595ec8d-d91a-4df3-a470-e7738ae8d90d 34 fields · synced May 30, 2026