Identity
- Trade Name
- EMSS EUDAMEDFDA UDI
- Generic Name
- Spine board FDA UDI
- Device Name
- Spine Board with Safety Belt EUDAMEDAmbulance Stretcher with Safety Belts EUDAMED
- Model / Reference
- EG-006 EUDAMEDFDA UDIEDJ-015C EUDAMEDEDJ-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737272556 EUDAMED06974737270064 EUDAMEDFDA UDI
- Basic UDI-DI
- 697473727SBSB0012M EUDAMED697473727ASSB001XV EUDAMED
- Direct Marketing DI
- 06974737272556 EUDAMED
- FDA Product Code
- MRI FDA UDI
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMEDV08050101 GENERIC USE STRETCHERS EUDAMED
- GMDN Term
- Spine board FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Portugal EUDAMEDNorway 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Emss by Shanghai Emss Med&Tech Co., Ltd — 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 | 697473727SBSB0012M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Emss Med&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000008860
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 56fbd76e-b2e9-4921-b1d4-4ac7855f00d2 61 fields · synced Jul 28, 2026
- EUDAMED 74d8869a-ef51-44c4-b62f-3c7f37f40256 61 fields · synced May 16, 2026
- FDA UDI 0279b1bb-4648-425b-95cb-a030762d5df3 32 fields · synced May 29, 2026