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Disposable Nitrile Gloves
EUDAMEDClass I (EU MDR)
Ref 2026042303Model FCH-3500-WHIRef 20260423Ref 2026042304Model FCH-3500-PINRef 2026042302Model FCH-3500-BLK
Identity
- Trade Name
- Disposable Nitrile Gloves EUDAMED
- Device Name
- Disposable Nitrile Gloves EUDAMEDFCH-3500-BLU EUDAMED
- Model / Reference
- FCH-3500-WHI EUDAMED2026042303 EUDAMED20260423 EUDAMEDFCH-3500-PIN EUDAMED2026042304 EUDAMEDFCH-3500-BLK EUDAMED2026042302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69786118835033 EUDAMED69786118835002 EUDAMED69786118835040 EUDAMED69786118835026 EUDAMED
- Basic UDI-DI
- 697861188FCH-3500-WHIH5 EUDAMED697861188FCH-3500-BLUEY EUDAMED697861188FCH-3500-PINGF EUDAMED697861188FCH-3500-BLKEC EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable Nitrile Gloves by First Choice Health Co., Ltd. — 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 | 697861188FCH-3500-WHIH5 | Class I | Active |
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Manufacturer
- Manufacturer
- First Choice Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000050349
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (4)
- EUDAMED 8cab8e7f-2e84-4879-ace0-0b3d0ef76e2a 61 fields · synced Jul 31, 2026
- EUDAMED ea56e28a-6a3b-446c-bd88-bc8a5fe21d4e 61 fields · synced May 18, 2026
- EUDAMED c5724b05-c1e7-492f-b991-ab39eeb67c41 61 fields · synced May 18, 2026
- EUDAMED 68a64e13-864d-44a7-893d-7f16a7cec33e 61 fields · synced May 18, 2026