← Back to catalogue
Mixing Pad
EUDAMEDClass I (EU MDR)
Ref 997005Model 996991,996992,996993,996994,996998,996999,996700,996701,997010,997006,997004,997008,997002,997011,997007,997005,997009,997003,997012,997013
Identity
- Device Name
- Mixing Pad EUDAMED
- Model / Reference
- 996991,996992,996993,996994,996998,996999,996700,996701,997010,997006,997004,997008,997002,997011,997007,997005,997009,997003,997012,997013 EUDAMED997005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970157298336 EUDAMED
- Basic UDI-DI
- 697015729MPZL EUDAMED
- Direct Marketing DI
- 06970157298336 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Dental impression tray, single-use
Mixing Pad by BH Medical Products Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
- Miratray Partiell PR 100er — Hager & Werken GmbH & Co. KG · Class I
- COE® — Gc America Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- EXCELLENT — PLASDENT CORP. · Class I
- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
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 | 697015729MPZL | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BH Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000017456
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 0f2580b9-5cf3-4c63-a59a-935a9d7f78bf 61 fields · synced Jul 26, 2026