BISSWÄLLE VORGEF. ORANGE (mittel) Orange
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BISSWÄLLE VORGEF. ORANGE (mittel) Orange EUDAMEDNA FDA UDI
- Generic Name
- Denture clasp, metal, custom-made FDA UDI
- Device Name
- Bisswälle EUDAMEDPreformed bite rims (medium) orange FDA UDI
- Model / Reference
- 62300 EUDAMEDFDA UDI
- Description
- Preformed bite rims (medium) orange FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB62300 EUDAMEDEGEB62300 FDA UDI
- Basic UDI-DI
- 42518579BissregWallH8 EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Denture clasp, metal, custom-made FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Silicone dental impression material
BISSWÄLLE VORGEF. ORANGE (mittel) Orange by Gebdi Dental-Products GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42518579BissregWallH8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- gebdi DENTAL-PRODUCTS GmbH
- EUDAMED SRN
- DE-MF-000005566
Sources (2)
- EUDAMED c425d65c-9bf2-4a29-82fb-8b8e4ef8e699 61 fields · synced Oct 6, 2026
- FDA UDI 537ee686-968e-4fdb-ae87-6dd9a80dd2db 33 fields · synced May 30, 2026