Identity
- Trade Name
- EMSS EUDAMEDFDA UDI
- Generic Name
- Head/neck immobilizer, reusable FDA UDI
- Device Name
- Head Immobilizer EUDAMEDBasket Stretcher with Safety Belts EUDAMED
- Model / Reference
- ET-001 EUDAMEDFDA UDIEDJ-016A EUDAMEDEDJ-016B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974737272006 EUDAMED06974737271016 EUDAMEDFDA UDI
- Basic UDI-DI
- 697473727HI001HZ EUDAMED697473727BSSB001YE EUDAMED
- Direct Marketing DI
- 06974737272006 EUDAMED
- FDA Product Code
- MRI FDA UDI
- EMDN Code
- M030599 IMMOBILISATION SYSTEMS AND DEVICES - OTHER EUDAMEDV08050101 GENERIC USE STRETCHERS EUDAMED
- GMDN Term
- Head/neck immobilizer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 FDA UDI
- Market of Registration
- Portugal EUDAMEDIceland 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 | 697473727HI001HZ | 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 aac53aa1-47db-49de-a1d5-6dc8606178e9 61 fields · synced Jul 19, 2026
- EUDAMED 9c9b9f44-65b8-49cb-87fd-2321a1946aef 61 fields · synced May 18, 2026
- FDA UDI c0649485-ed41-4bef-980c-2781d01b4333 32 fields · synced May 30, 2026