Identity
- Trade Name
- Bodymate FDA UDI
- Generic Name
- Hip orthosis FDA UDI
- Model / Reference
- M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973712280029 FDA UDI
- FDA Product Code
- ITQ FDA UDI
- GMDN Term
- Hip orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hip orthosis
Bodymate by Hengshui Tianjian Medical Supplies CO., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip orthosis.
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- ManaMed Inc — MANAMED LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- Vive — VIVE HEALTH LLC · Class I
- MECRON Hip-Compression U: 105-125 cm — Darco (Europe) GmbH · Class I
- MECRON Hip-Spica U: 95-115 cm — Darco (Europe) GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hengshui Tianjian Medical Supplies CO., LTD
Sources (1)
- FDA UDI 59495279-e5ea-450e-a874-14ed0dd7b86a 32 fields · synced May 30, 2026