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Inspire Nitrile Powder Free Examination Gloves
EUDAMEDFDA 510(k)Class I (EU MDR)
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Identity
- Trade Name
- Inspire Nitrile Powder Free Examination Gloves EUDAMED
- Device Name
- Nitrile Powder Free examination Glove EUDAMED
- Model / Reference
- 33881 EUDAMED33891 EUDAMED33871 EUDAMED3387 EUDAMED3385 EUDAMED33851 EUDAMED3386 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555123608929 EUDAMED09555123608936 EUDAMED09555123608912 EUDAMED09555123603825 EUDAMED09555123603801 EUDAMED09555123608899 EUDAMED09555123603818 EUDAMED
- Basic UDI-DI
- 955512360CISBPFNNB EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Inspire Nitrile Powder Free Examination Gloves by Cranberry International Sdn. Bhd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K983334 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 955512360CISBPFNNB | Class I | Active |
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Manufacturer
- Manufacturer
- Cranberry International Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000004878
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED 342b19b5-a1e0-4176-94c9-008a1c73978d 61 fields · synced Jul 27, 2026
- EUDAMED 83a77cc8-39c5-4f0b-82b4-915b79db2b3b 61 fields · synced May 16, 2026
- EUDAMED 702e06e6-11a1-4897-a6a4-63e65a941cd2 61 fields · synced May 17, 2026
- EUDAMED f6afd94d-d987-4b75-be75-13380513fde3 61 fields · synced May 17, 2026
- EUDAMED 7f21ce45-5962-4f4b-9f2b-b7c2d4076a47 61 fields · synced May 18, 2026
- EUDAMED ed45bd9e-be51-4182-8cb7-1302725c472b 61 fields · synced May 18, 2026
- EUDAMED 01669d06-13d1-4bef-9761-66fb782ca81e 61 fields · synced May 18, 2026
- FDA 510(k) K983334 1 fields · synced May 18, 2026