Identity
- Trade Name
- GAMMA 3.2 FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- GAMMA 3.2 ACOUSTIC X-Serie FDA UDI
- Model / Reference
- 000 FDA UDI
- Description
- GAMMA 3.2 ACOUSTIC X-Serie FDA UDI
Identifiers
- Catalog Number
- M-000.09.947 FDA UDI
- Primary DI / UDI-DI
- 04053755203048 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
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mechanical external stethoscope
Gamma 3.2 by Heine Optotechnik GmbH & Co. KG — 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
- Heine Optotechnik GmbH & Co. KG
Sources (1)
- FDA UDI e1a5f9e2-017d-4b86-a614-a20e8a08a41f 35 fields · synced Jun 1, 2026