Identity
- Trade Name
- Alleset FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- Equipment Covers EUDAMEDFlexible light handle cover_Green_Sterile_160EA/CS FDA UDI
- Model / Reference
- 25-3011-S2 EUDAMEDModel 25-3011-S2 FDA UDI
- Description
- Flexible light handle cover_Green_Sterile_160EA/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16931918173153 EUDAMEDFDA UDI
- Basic UDI-DI
- 69319181F008KZ EUDAMED
- FDA Product Code
- FTA FDA UDI
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Vascular booties
Equipment Covers by GRI Medical & Electronic 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69319181F008KZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004203
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 03b7cce3-43ce-45d0-8e5e-5e8197b18528 61 fields · synced Sep 18, 2026
- FDA UDI 4c19caae-3f5d-4ef5-8600-df7c2c12098a 34 fields · synced May 30, 2026