Identity
- Trade Name
- Achilles EXPII FDA UDI
- Generic Name
- Bone absorptiometric ultrasound system FDA UDI
- Device Name
- BONE ULTRASONOMETER, ACHILLES FDA UDI
- Model / Reference
- v1 FDA UDI
- Description
- BONE ULTRASONOMETER, ACHILLES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682116978 FDA UDI
- 510(k) Number
- K103633 FDA UDI
- FDA Product Code
- MUA FDA UDI
- GMDN Term
- Bone absorptiometric ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1180 FDA UDI
- Commercial Distribution
- Not 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
Achilles EXPII by GE Medical Systems (China) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- GE Medical Systems (China) Co., Ltd.
Sources (1)
- FDA UDI 3936b9bc-1347-4b36-81d3-47032261b4e7 36 fields · synced May 30, 2026