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Examination Gloves
EUDAMEDClass I (EU MDR)
Ref PVC16D01Model PVC16D01, NITRILE16D02, SYN16D03, LATEX16D04
Identity
- Device Name
- Examination Gloves EUDAMED
- Model / Reference
- PVC16D01, NITRILE16D02, SYN16D03, LATEX16D04 EUDAMEDPVC16D01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976800670429 EUDAMED
- Basic UDI-DI
- 697680067EGlovesUC EUDAMED
- EMDN Code
- T010299 EXAMINATION / TREATMENT GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Examination Gloves by Sinopharm Fortune International Trading Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697680067EGlovesUC | Class I | Active |
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Manufacturer
- Manufacturer
- Sinopharm Fortune International Trading Corp.
- EUDAMED SRN
- CN-MF-000038309
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 234f2c05-a28c-4c95-84b4-209749614736 61 fields · synced Jul 20, 2026