Disposable Amies Sampling Kit
by Guangxi Huadu Medical Equipment Co., Ltd.
Model B-1.0、B -1.5、B -2.0、B -2.5、B -3.0、B -3.5、B -4.0、B -4.5、B -5.0、B -5.5、B -6.0、B -6.5、B -7.0、B -7.5、B -8.0、B -8.5 and so on
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697442703ATMRP 06974427030008 | Date12 Aug 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Disposable Amies Sampling Kit
- Model / Reference
- B-1.0、B -1.5、B -2.0、B -2.5、B -3.0、B -3.5、B -4.0、B -4.5、B -5.0、B -5.5、B -6.0、B -6.5、B -7.0、B -7.5、B -8.0、B -8.5 and so on
- Primary DI / UDI-DI
- 06974427030008
- Basic UDI-DI
- 697442703ATMRP
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000026592
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No