Identity
- Trade Name
- Gloves EUDAMEDEMSRUN FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Gloves EUDAMED
- Model / Reference
- CR-GV08 EUDAMEDPZST0013-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567745350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06974567745350 EUDAMED
- FDA Product Code
- LZA FDA UDI
- EMDN Code
- V901603 SUPERFICIAL TREATMENTS INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 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
Gloves by Wuxi Emsrun Technology Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-06974567745350 | 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 cc4b1964-1b3c-4970-9abc-7f48243711fd 61 fields · synced Jul 18, 2026
- FDA UDI b55ccc84-601c-478f-9426-c1a8c1e9b2e9 32 fields · synced May 30, 2026