CRYO.S, BIOBANKING TUBES, 1000µl, SC BLUE
Ref 978584
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number4039943001629P 34039943001628 | Date8 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number34039943001628 | Date6 Dec 2022 | StatusListed |
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- Withdrawn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
- United States
Specification
- Trade Name
- Cryo.s
- Generic Name
- General specimen container IVD, no additive/medium
- Device Name
- CRYO.S,BIOBANKING TUBES,1000µl, SC BLUE
- Model / Ref / Catalog
- 978584
- Primary DI / UDI-DI
- 34039943001628 EUDAMED14039943001624 GUDID
- Basic UDI-DI
- 4039943001629P
- Direct Marketing DI
- 34039943001628
- FDA Product Code
- KDT
- EMDN Code
- W05020199 Samples transport, containers - other
- GMDN Term
- General specimen container IVD, no additive/medium
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 864.3250
- EU market of registration
- Germany
- GUDID distribution status
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 34039943001628 | 14039943001624 |
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- DE-MF-000032396
Other devices from Greiner Bio - One GmbH
Properties
Other properties (21)
- Sterile: No
- Implantable: No
- Contains Latex: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Serial Number: No
- Manufacturing Date: No