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ClotChek Liquid Quality Controls Kit, Global
EUDAMEDClass IVD General (EU MDR)
Ref 1100029
Identity
- Trade Name
- ClotChek Liquid Quality Controls Kit, Global EUDAMED
- Device Name
- ClotChek Liquid Quality Controls Kit, Global EUDAMED
- Model / Reference
- 1100029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850032840088 EUDAMED
- Basic UDI-DI
- B-00850032840088 EUDAMED
- EMDN Code
- W0202020185 COAGULOMETERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ClotChek Liquid Quality Controls Kit, Global by Perosphere Technologies Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850032840088 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Perosphere Technologies Inc.
- EUDAMED SRN
- US-MF-000048660
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED a3018661-55b5-4a40-9c09-ae76c6c38fbc 61 fields · synced Jul 10, 2026