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Micrograft gauze + cork plate, 1:2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2.2/1
by Humeca B.V.
Identity
- Trade Name
- Micrograft gauze + cork plate, 1:2 FDA UDI
- Generic Name
- Woven gauze pad, non-antimicrobial FDA UDI
- Device Name
- Micrograft gauze + cork plate, 1:2 EUDAMED
- Model / Reference
- 2.2/1 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2.2/1 FDA UDI
- Primary DI / UDI-DI
- 08717903490006 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490006 EUDAMED
- FDA Product Code
- GFD FDA UDI
- EMDN Code
- M0299 GAUZES - OTHER EUDAMED
- GMDN Term
- Woven gauze pad, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Micrograft gauze + cork plate, 1:2 by Humeca B.V. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717903490006 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Humeca B.V.
- EUDAMED SRN
- NL-MF-000010933
Sources (2)
- EUDAMED 8a172880-fa7a-4116-8197-bcf83398cdce 61 fields · synced Jun 20, 2026
- FDA UDI 36d0591e-a48d-4b09-a8b9-fde2a4ad8866 33 fields · synced May 30, 2026