Identity
- Trade Name
- Birthing Sling Manual FDA UDI
- Generic Name
- Manual patient lifting belt/harness FDA UDI
- Device Name
- Manual Handling Aids EUDAMED
- Model / Reference
- BIRTH1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056387405148 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040783ManualAidsD9 EUDAMED
- Direct Marketing DI
- 05056387405148 EUDAMED
- FDA Product Code
- INE FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- Manual patient lifting belt/harness FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Manual Handling Aids by Silvalea Limited — 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 | 506040783ManualAidsD9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Silvalea Limited
- EUDAMED SRN
- GB-MF-000003832
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED d751b818-881f-45a5-90ba-3c703978524d 61 fields · synced Jun 18, 2026
- FDA UDI ac115d0d-450c-440e-aff0-1256d3b5dbea 32 fields · synced May 30, 2026