Identity
- Trade Name
- EMSRUN FDA UDI
- Generic Name
- Rescue blanket, reusable FDA UDI
- Device Name
- EMERGENCY BLANKET EUDAMED
- Model / Reference
- CR-070 EUDAMEDCR-073 EUDAMEDPZJJ0024 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567745312 EUDAMEDFDA UDID-069745677453432D EUDAMED
- Basic UDI-DI
- B-06974567745312 EUDAMEDB-069745677453432D EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Rescue blanket, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Emergency Blanket by Wuxi Emsrun Technology Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974567745312 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008968
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 2ee35499-f477-4b5f-beaa-9df12dee6f23 61 fields · synced Aug 1, 2026
- EUDAMED 59397f22-e56a-40ba-a4ae-744bbe7f6d23 61 fields · synced May 17, 2026
- FDA UDI 62f6dc27-eb4e-419a-b74c-cdcd22a321b2 32 fields · synced May 30, 2026