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dermagel micro
EUDAMEDClass IIa (EU MDR)
Ref RC10076055_0016Ref RC10076070_0016Ref RC10076085_0016
Identity
- Trade Name
- dermagel micro EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powder Free EUDAMED
- Model / Reference
- RC10076055_0016 EUDAMEDRC10076070_0016 EUDAMEDRC10076085_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363504519 EUDAMED00806363504540 EUDAMED00806363504571 EUDAMED
- Basic UDI-DI
- 806363LSGFM4 EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
dermagel micro 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 (3)
- EUDAMED d59efeb3-0999-466a-993f-c4da350ef8d3 61 fields · synced Oct 6, 2026
- EUDAMED 1d32ea4b-060d-4804-aee7-75d27af74ccb 61 fields · synced Jul 14, 2026
- EUDAMED 403badb2-bfd2-4925-b854-c3a64f7b37c4 61 fields · synced Jul 15, 2026