Identity
- Trade Name
- PALAMIX vacuum pump EUDAMEDPALAMIX® FDA UDI
- Generic Name
- Orthopaedic material preparation vacuum pump FDA UDI
- Device Name
- PALAMIX vacuum pump EUDAMEDReusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum FDA UDI
- Model / Reference
- 66036748 EUDAMEDVacuum Pump FDA UDI
- Description
- Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum FDA UDI
Identifiers
- Catalog Number
- 66036748 FDA UDI
- Primary DI / UDI-DI
- 04260102131231 EUDAMEDFDA UDI
- Basic UDI-DI
- 42601021304010001HN EUDAMED
- FDA Product Code
- JDY FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic material preparation vacuum pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4220 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic material preparation vacuum pump
Palamix® by Heraeus Medical LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic material preparation vacuum pump.
- EASYMIX® vacuum pump I — OSARTIS GmbH · Class I
- EASYMIX® vacuum pump II — OSARTIS GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (2)
- FDA UDI 63cf5226-050e-49ec-97ba-d740b189d2ac 34 fields · synced Jul 8, 2026
- EUDAMED a0dca9c7-8cb7-440c-a321-8fb3485b9b10 61 fields · synced Jul 8, 2026