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dermagel neopren
EUDAMEDClass IIa (EU MDR)
Ref RC40080055_0016Ref RC40080085_0016Ref RC40080065_0016Ref RC40080075_0016Ref RC40080070_0016
Identity
- Trade Name
- dermagel neopren EUDAMED
- Device Name
- Sterile Synthetic Surgical Gloves Powder Free – Poly Chloroprene EUDAMED
- Model / Reference
- RC40080055_0016 EUDAMEDRC40080085_0016 EUDAMEDRC40080065_0016 EUDAMEDRC40080075_0016 EUDAMEDRC40080070_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363504816 EUDAMED00806363504878 EUDAMED00806363504830 EUDAMED00806363504854 EUDAMED00806363504847 EUDAMED
- Basic UDI-DI
- 806363SPGFN6 EUDAMED
- EMDN Code
- T01010201 POLYCHLOROPREN 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
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
dermagel neopren 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 | 806363SPGFN6 | 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 (5)
- EUDAMED 23e92bd5-0e4f-4be3-b53a-abad41e710f1 61 fields · synced Oct 6, 2026
- EUDAMED 86e4bc36-bde4-490b-95cd-c18a666e3850 61 fields · synced Jul 15, 2026
- EUDAMED 311726dd-8922-485c-9119-cd7c44b5ed3b 61 fields · synced Jul 16, 2026
- EUDAMED cc52eb03-2ff9-44da-aa94-f8e61afc6a9e 61 fields · synced Jul 25, 2026
- EUDAMED c89bc54a-850d-48c9-80c1-3de81e89d895 61 fields · synced Aug 2, 2026