Esmark Bandage
by GRI Medical & Electronic Technology Co., Ltd. China EUDAMEDGUDID
Ref 25-6120-S Product code FQMEMDN M0304010103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69319181F009L3 | Date22 Jun 2023 | StatusActive |
| United States | GUDID listing GUDID | Number16931918145129 | Date20 Feb 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Alleset
- Generic Name
- General-purpose endoscopic needle, single-use
- Model / Reference
- 25-6120-S EUDAMEDModel 25-6120-S GUDID
- Primary DI / UDI-DI
- 16931918145129
- Basic UDI-DI
- 69319181F009L3
- FDA Product Code
- FQM
- EMDN Code
- M0304010103 Elastic compression bandages, non-adhesive, high extensibility (>140%)
- GMDN Term
- General-purpose endoscopic needle, single-use
- Device Class
- Class I
- Regulation Number
- 880.5075
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Ethylene Oxide
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 25-6120-S | Model 25-6120-S |
Manufacturer details
- EUDAMED SRN
- CN-MF-000004203
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from GRI Medical & Electronic Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED faedeb50-706a-4ada-b212-f5420e2b077c
- FDA UDI 65709a78-2e01-4cad-afeb-8550f56795c9