Identity
- Trade Name
- Disk EUDAMEDAquatec Rotary Disk- Blue FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Disk EUDAMEDAquatec Rotary Disk- Blue FDA UDI
- Model / Reference
- 4.02.002 EUDAMEDFDA UDI
- Description
- Aquatec Rotary Disk- Blue FDA UDI
Identifiers
- Catalog Number
- 4.02.002 FDA UDI
- Primary DI / UDI-DI
- 04028698076462 EUDAMEDFDA UDI
- Basic UDI-DI
- 4028698DiskC5 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- V080504 PATIENT TRANSFER BOARDS AND TABLES EUDAMED
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Patient lifting system stretcher
Disk by Invacare GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient lifting system stretcher.
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
- Symphony™ — Qfix · Class II
- Transfer board — Mobilex A/S · Class I
- Powered Loading System (PLS) (Component) — LIFEPORT, LLC. · Class I
- INSTALLATION, POWER LOADING SYSTEM, CESSNA 680 * PLS — LIFEPORT, LLC. · Class I
- Applicator Clamp Holder — Qfix · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4028698DiskC5 | Class I | Active |
| 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
- Invacare GmbH
- EUDAMED SRN
- DE-MF-000006985
Sources (2)
- EUDAMED 15345f2f-1c84-47dd-9136-36979f5e5ed7 61 fields · synced Jul 10, 2026
- FDA UDI 5a339bba-d4e9-41ce-ae8a-51c2e48d0017 35 fields · synced May 30, 2026