Identity
- Trade Name
- SHEKO Kalorien Blocker 2in1 EUDAMED
- Device Name
- Carb & Fatblocker EUDAMED
- Model / Reference
- 053615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-053615NE EUDAMED
- Basic UDI-DI
- B-053615NE EUDAMED
- EMDN Code
- G0402 ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
SHEKO Kalorien Blocker 2in1 by PK Benelux BV — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-053615NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED 90ab20a0-861a-43c0-9a39-ee77db81472c 61 fields · synced Jun 18, 2026