Identity
- Trade Name
- Sleeve heavy-duty1 FDA UDI
- Generic Name
- Prosthesis suspension system FDA UDI
- Device Name
- sleeve worn over residual limb/socket FDA UDI
- Model / Reference
- SA900 FDA UDI
- Description
- sleeve worn over residual limb/socket FDA UDI
Identifiers
- Catalog Number
- SA9001H FDA UDI
- Primary DI / UDI-DI
- 04260652350106 FDA UDI
- FDA Product Code
- ISS FDA UDI
- GMDN Term
- Prosthesis suspension system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Prosthesis suspension system
Sleeve heavy-duty1 by Romedis GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prosthesis suspension system.
- Sleeve Office1 — Romedis GmbH · Class I
- Sleeve heavy-duty2 — Romedis GmbH · Class I
- Sleeve heavy-duty3 — Romedis GmbH · Class I
- Sleeve Office3 — Romedis GmbH · Class I
- Sleeve heavy-duty4 — Romedis GmbH · Class I
- Sleeve Office4 — Romedis GmbH · Class I
- Sleeve Office2 — Romedis 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 |
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Manufacturer
- Manufacturer
- Romedis GmbH
Sources (1)
- FDA UDI d6ade1cb-5e0f-44ca-b191-79e84388b263 34 fields · synced May 30, 2026