Identity
- Trade Name
- EMERGENCY BLANKET EUDAMEDEMSRUN FDA UDI
- Generic Name
- Rescue blanket, reusable FDA UDI
- Device Name
- EMERGENCY BLANKET EUDAMED
- Model / Reference
- CR-080 EUDAMEDPZJJ0022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567742922 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774130*210cm5F EUDAMED
- Direct Marketing DI
- 06974567742922 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Emergency Blanket by Wuxi Emsrun Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697456774130*210cm5F | 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 (2)
- EUDAMED 8ab731ee-7fb1-486f-ab8c-ee653a9b74e6 61 fields · synced Jun 18, 2026
- FDA UDI 0c6c4966-a349-4fb1-abbf-ab2e2a1a07f1 32 fields · synced May 30, 2026