Identity
- Trade Name
- GRAM IODINE 250MLX5 EUDAMEDREMEL FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- GRAM IODINE EUDAMEDGRAM IODINE BTLx5/250 ML FDA UDI
- Model / Reference
- R40057 EUDAMEDFDA UDI
- Description
- GRAM IODINE BTLx5/250 ML FDA UDI
Identifiers
- Catalog Number
- R40057 FDA UDI
- Primary DI / UDI-DI
- 00848838065606 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380GrStIodineSM EUDAMED
- FDA Product Code
- HYI FDA UDI
- EMDN Code
- W0104010804 STAINS EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gram Iodine 250mlx5 by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380GrStIodineSM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED eabe8bb9-d5e3-4793-a784-49c28794d7d5 61 fields · synced Jun 18, 2026
- FDA UDI 52a88731-d601-4bef-96ac-f531eb3fbd79 34 fields · synced May 30, 2026