Identity
- Trade Name
- Surgicare Ortho EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powder Free EUDAMED
- Model / Reference
- 255/5.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363507718 EUDAMED
- Basic UDI-DI
- 806363LSGFM4 EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Surgicare Ortho by Kanam Latex Industries Private Limited — Class IIa — 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 | 806363LSGFM4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kanam Latex Industries Private Limited
- EUDAMED SRN
- IN-MF-000022741
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED d007cfd0-edb2-4d24-98ac-3e0b3622daac 61 fields · synced Jul 15, 2026