Identity
- Trade Name
- BIOS Living FDA UDI
- Generic Name
- Earplugs, single-use FDA UDI
- Device Name
- Tapered Foam Ear Plugs With Keychain 4 PC Orange 32dB with 2 Keychains FDA UDI
- Model / Reference
- EP125 FDA UDI
- Description
- Tapered Foam Ear Plugs With Keychain 4 PC Orange 32dB with 2 Keychains FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00057475561253 FDA UDI
- FDA Product Code
- EWD FDA UDI
- GMDN Term
- Earplugs, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earplugs, single-use
BIOS Living by Thermor Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Acu-Life (HE) — Apothecary Products, Inc. · U
- Meniett™ Earplug, Clear, 19 mm — Lina Medical ApS · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Thermor Ltd
Sources (1)
- FDA UDI b7d80a7d-b234-4ca9-ad4f-9a3fb321af2b 33 fields · synced Jun 8, 2026