Identity
- Trade Name
- Medikro Grip EUDAMEDM91227-25, Medikro® Grip FDA UDI
- Generic Name
- Electrical cable/lead holder FDA UDI
- Model / Reference
- M91227 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06420099001018 EUDAMED06420099000691 FDA UDI
- Basic UDI-DI
- 6420099M91227B4 EUDAMED
- FDA Product Code
- BYX FDA UDI
- EMDN Code
- Z12150199 SPIROMETRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electrical cable/lead holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Medikro Grip by Medikro Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6420099M91227B4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medikro Oy
- EUDAMED SRN
- FI-MF-000011841
Sources (2)
- EUDAMED 6dde82ea-9ddf-4aeb-8099-1934515bf14c 61 fields · synced Jun 18, 2026
- FDA UDI 64a12869-8160-47c7-90dd-27e41bda19b6 32 fields · synced May 30, 2026