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RevoFit® Lamination Fabricators 10-Pack with Click® Reel
EUDAMEDClass I (EU MDR)
Ref RF-200-07-10
Identity
- Trade Name
- RevoFit® Lamination Fabricators 10-Pack with Click® Reel EUDAMED
- Device Name
- RevoFit and RevoSurface Kits EUDAMED
- Model / Reference
- RF-200-07-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028855027 EUDAMED
- Basic UDI-DI
- 0850028855PK200032097 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
RevoFit® Lamination Fabricators 10-Pack with Click® Reel by Click Medical LLC — 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 | 0850028855PK200032097 | Class I | Active |
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Manufacturer
- Manufacturer
- Click Medical LLC
- EUDAMED SRN
- US-MF-000031805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ef891e29-fdbd-4255-834a-051b5c78acee 61 fields · synced Jun 19, 2026