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dermagel coated
EUDAMEDClass IIa (EU MDR)
Ref RC10075055_0016Ref RC10074055_0016Ref RC10075070_0016Ref RC10075075_0016Ref RC10074070_0016Ref RC10074075_0016Ref RC10074065_0016Ref RC10074085_0016Ref RC10075090_0016Ref RC10074080_0016
Identity
- Trade Name
- dermagel coated EUDAMED
- Device Name
- Sterile Latex Surgical Gloves Powder Free EUDAMED
- Model / Reference
- RC10075055_0016 EUDAMEDRC10074055_0016 EUDAMEDRC10075070_0016 EUDAMEDRC10075075_0016 EUDAMEDRC10074070_0016 EUDAMEDRC10074075_0016 EUDAMEDRC10074065_0016 EUDAMEDRC10074085_0016 EUDAMEDRC10075090_0016 EUDAMEDRC10074080_0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00806363504410 EUDAMED00806363504311 EUDAMED00806363504441 EUDAMED00806363504458 EUDAMED00806363504342 EUDAMED00806363504359 EUDAMED00806363504335 EUDAMED00806363504373 EUDAMED00806363504489 EUDAMED00806363504366 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 coated 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 (10)
- EUDAMED ba9f9e59-cd36-4e33-bff5-7f81a9788ef7 61 fields · synced Oct 6, 2026
- EUDAMED ae5001ad-afdf-4d7e-a8aa-675b40c17206 61 fields · synced May 18, 2026
- EUDAMED 5eceb621-5138-4664-9f78-4036c9a7dc3a 61 fields · synced Jul 9, 2026
- EUDAMED 40dd580b-f5b1-4373-954b-9ce03a9c8d7a 61 fields · synced Jul 11, 2026
- EUDAMED 9b83d1ad-c61b-4223-a403-602c89cbcf70 61 fields · synced Jul 14, 2026
- EUDAMED ba8870a9-a5c5-49dc-b413-6b10a5e94d8e 61 fields · synced Jul 15, 2026
- EUDAMED 29eb90b6-1361-4bb3-af98-53dcf61eab2f 61 fields · synced Jul 17, 2026
- EUDAMED 35b3e023-c1eb-494f-abc6-9c69bd79d640 61 fields · synced Jul 26, 2026
- EUDAMED c22d4a84-a0a2-45b8-bea2-80be71affffd 61 fields · synced Jul 29, 2026
- EUDAMED f2cb6727-9a13-4564-96b7-d6728729267b 61 fields · synced Aug 1, 2026