Identity
- Trade Name
- Bioseal Inc. FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- Neonatal Stethoscope FDA UDI
- Model / Reference
- 18302/10 FDA UDI
- Description
- Neonatal Stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00630094183022 FDA UDI
- FDA Product Code
- LDE FDA UDI
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical external stethoscope
Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical external stethoscope.
- Sklar® — Sklar Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
- Stethoscope — Rashman Corp. · Class I
- Greater Goods — Greater Goods, LLC · Class I
- Stethoscope — Rashman Corp. · Class I
- 3M™ Littmann® Classic III™ — 3M COMPANY · Class I
- Proscope™ — American Diagnostic Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bioseal
Sources (1)
- FDA UDI c7b1b66e-d471-4252-8c1a-da69e0e78f68 33 fields · synced May 31, 2026