Identity
- Trade Name
- BTL Vanquish ME FDA UDI
- Generic Name
- Hyperthermia system gantry FDA UDI
- Model / Reference
- BTL Vanquish ME FDA UDI
Identifiers
- Primary DI / UDI-DI
- B108713POUNITUS0 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Hyperthermia system gantry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hyperthermia system gantry
BTL Vanquish ME by BTL Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hyperthermia system gantry.
- Exilis large applicator — BTL Industries, Inc. · Class II
- Exilis large applicator — BTL Industries, Inc. · Class II
- Exilis small applicator — BTL Industries, Inc. · Class II
- Vanquish Applicator — BTL Industries, Inc. · Class II
- BTL Exilis Protégé — BTL Industries, Inc. · Class II
- Vanquish Applicator — BTL Industries, Inc. · Class II
- Vanquish Applicator — BTL Industries, Inc. · Class II
- XP applicator — BTL Industries, Inc. · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA UDI af5686e4-4483-42e7-92ca-f79980239128 32 fields · synced Jun 1, 2026