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Intraoperative PU Probe Cover
EUDAMEDClass IIa (EU MDR)
Ref E6341AModel Intraoperative PU Probe Cover
Identity
- Device Name
- Intraoperative PU Probe Cover EUDAMED
- Model / Reference
- Intraoperative PU Probe Cover EUDAMEDE6341A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424197039 EUDAMED
- Basic UDI-DI
- 697542419EC49JB EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Intraoperative PU Probe Cover by Exact Medical Manufacturing, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697542419EC49JB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (1)
- EUDAMED 9bc059a4-bcd8-4b83-980d-40cbd7046a6e 61 fields · synced Jun 18, 2026