Identity
- Device Name
- Adhesive Prep Glove EUDAMED
- Model / Reference
- PG001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649995283260 EUDAMED
- Basic UDI-DI
- 7649995PG00165 EUDAMED
- Direct Marketing DI
- 07649995283260 EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia 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
Category: Cranial bur, single-use
Adhesive Prep Glove by ME Medical AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cranial bur, single-use.
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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 | 7649995PG00165 | Class I | Active |
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Manufacturer
- Manufacturer
- ME Medical AG
- EUDAMED SRN
- CH-MF-000052198
- Authorised Representative
- KAHLITY France SAS FR-AR-000018313
Sources (1)
- EUDAMED 227e0903-83e9-4741-96ec-b89d025af30e 61 fields · synced Jul 31, 2026