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Disposable Instrument Isolation Cover
EUDAMEDClass I (EU MDR)
Ref FM-609Ref FM-605Ref FM-610Ref FM-607Ref FM-608Ref FM-606Ref FM-603Ref FM-611Ref FM-613
Identity
- Trade Name
- Disposable Instrument Isolation Cover EUDAMED
- Device Name
- Disposable Instrument Isolation Cover EUDAMED
- Model / Reference
- FM-609 EUDAMEDFM-605 EUDAMEDFM-610 EUDAMEDFM-607 EUDAMEDFM-608 EUDAMEDFM-606 EUDAMEDFM-603 EUDAMEDFM-611 EUDAMEDFM-613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272660909 EUDAMED06942272660503 EUDAMED06942272661005 EUDAMED06942272660701 EUDAMED06942272660800 EUDAMED06942272660602 EUDAMED06942272660305 EUDAMED06942272661104 EUDAMED06942272661302 EUDAMED
- Basic UDI-DI
- 69422726PU15120JC EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable Instrument Isolation Cover by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU) — Class I — 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 | 69422726PU15120JC | Class I | Active |
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Manufacturer
- Manufacturer
- FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- EUDAMED SRN
- CN-MF-000009645
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (9)
- EUDAMED e22dcfec-444f-4f10-91ec-75c5107eb875 61 fields · synced Oct 6, 2026
- EUDAMED 47d89dc2-8698-45d6-b661-327e6d00d0e4 61 fields · synced May 16, 2026
- EUDAMED 0ffd4733-c1c6-423f-8376-a9c9e37fe70d 61 fields · synced May 16, 2026
- EUDAMED d1d72e72-0d0d-49d5-ba9f-4d283c348a00 61 fields · synced May 16, 2026
- EUDAMED dcb07d65-9bd4-4377-a019-75c5dcb2c8b2 61 fields · synced May 17, 2026
- EUDAMED 3f7ad5b1-152e-409a-8a85-56a9cd81e113 61 fields · synced May 17, 2026
- EUDAMED f0e44e7e-cfb6-420a-9347-2dc9e796c21a 61 fields · synced May 17, 2026
- EUDAMED f3763d1d-1386-41c9-a8a7-761955717a66 61 fields · synced May 18, 2026
- EUDAMED 09da6972-fa7b-411c-bdb4-f50aabd5a1a9 61 fields · synced May 18, 2026