← Back to catalogue
Rapid Readout Biological indicator / Biological indicator
EUDAMEDClass I (EU MDR)
Ref CFBI0102Model CFBI0101, CFBI0102, CFBI0103, CFBI0104, CFBI0105, CFBI0106, CFBI0107, CFBI0108, CFBI0109, CFBI0201, CFBI0202, CFBI0203, CFBI0204, CFBI0205, CFBI0206, CFBI0207, CFBI0208, CFBI0209, etc
Identity
- Device Name
- Rapid Readout Biological indicator / Biological indicator EUDAMED
- Model / Reference
- CFBI0101, CFBI0102, CFBI0103, CFBI0104, CFBI0105, CFBI0106, CFBI0107, CFBI0108, CFBI0109, CFBI0201, CFBI0202, CFBI0203, CFBI0204, CFBI0205, CFBI0206, CFBI0207, CFBI0208, CFBI0209, etc EUDAMEDCFBI0102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976571930111 EUDAMED
- Basic UDI-DI
- 697657193BI01MW EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Sterilizer/disinfector rack
Rapid Readout Biological indicator / Biological indicator by HUBEI Cfull Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Sterilizer/disinfector rack.
- Niagara — MEDISAFE UK LIMITED · Class II
- Chemical Test Packs — Nantong Ineuthink Medical Technology Co., Ltd · Class I
- Padlock Security Tags — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Padlock Security Tags — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Accessoire pour stérilisation — MV2G INTERNATIONAL · Class I
- InnoWave — MEDISAFE UK LIMITED · Class II
- Padlock Security Tags — BATRIK MEDICAL MANUFACTURING INC. · Class I
- SF160 — Memmert GmbH + Co.KG · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697657193BI01MW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HUBEI Cfull Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047208
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 23549c9e-b78a-4f7e-b6be-69c6ed651ea7 61 fields · synced Jun 19, 2026