Identity
- Trade Name
- EB8000 EUDAMEDErgobench Adjustment Table FDA UDI
- Generic Name
- Traction table, manual FDA UDI
- Device Name
- Mechanical Tables (non-powered) EUDAMED
- Model / Reference
- EB8000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008449598 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008449NonpoweredAD EUDAMED
- Direct Marketing DI
- 00850008449598 EUDAMED
- FDA Product Code
- INW FDA UDI
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
- GMDN Term
- Traction table, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3750 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Eb8000 by Pivotal Health Solutions, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0850008449NonpoweredAD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pivotal Health Solutions
- EUDAMED SRN
- US-MF-000042753
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4ba2c7e5-1944-46ff-a60a-bd0c66c0fd83 61 fields · synced Jul 9, 2026
- FDA UDI 86518867-4f6d-426f-a6e2-a4efd12bf699 32 fields · synced May 30, 2026