Identity
- Trade Name
- Care Wise C-Trak Apollo Analyser EUDAMED
- Device Name
- Care Wise C-Trak Apollo Analyser EUDAMED
- Model / Reference
- CW4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B939CW5APO1060 EUDAMED
- Basic UDI-DI
- ++B939CW4000RE EUDAMED
- Direct Marketing DI
- +B939CW5APO1060 EUDAMED
- EMDN Code
- Z11029001 BETA/GAMMA DETECTORS EUDAMED
Classification
- Device Class
- Class IIa 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: Hand-held-detector nuclear medicine system
Care Wise C-Trak Apollo Analyser by Southern Scientific Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held-detector nuclear medicine system.
- EUROPROBE — EURORAD 2-6 · Class IIa
- Gamma Finder® II — W.O.M. World of Medicine GmbH · Class I
- EUROPROBE — EURORAD 2-6 · Class IIa
- EUROPROBE — EURORAD 2-6 · Class IIa
- EUROPROBE — EURORAD 2-6 · Class IIa
- Lara Sensor, Type 7 — Lucerno Dynamics, LLC · Class I
- neoprobe — Devicor Medical Products, Inc. · Class I
- GAMMAPRO LAP — GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. · Class IIa
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 | ++B939CW4000RE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Southern Scientific Ltd
- EUDAMED SRN
- GB-MF-000018418
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 8af00076-3cd9-4e25-90aa-a6ea0b513ac3 61 fields · synced Jun 19, 2026