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Hygiene Bag Size 3 200 Pcs

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 900478-DEX

by PaloDEx Group Oy

Identity

Trade Name
HYGIENE BAG SIZE 3 200 PCS EUDAMED
Hygiene bag for Imaging Plate Systems SIZE 3 200 PCS FDA UDI
Generic Name
Medical equipment drape, single-use, non-sterile FDA UDI
Device Name
Protective bags EUDAMED
Model / Reference
900478-DEX EUDAMED
900478 FDA UDI

Identifiers

Primary DI / UDI-DI
06430035873234 EUDAMEDFDA UDI
Basic UDI-DI
643003587HygieneSheath4N EUDAMED
510(k) Number
K133231 FDA UDI
FDA Product Code
PEM FDA UDI
EMDN Code
Z11030485 INSTRUMENTS FOR DIGITAL ENDORAL RADIOLOGY - CONSUMABLES EUDAMED
GMDN Term
Medical equipment drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Market of Registration
Finland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Hygiene Bag Size 3 200 Pcs by PaloDEx Group Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PaloDEx Group Oy
EUDAMED SRN
FI-MF-000004943

Sources (2)

  • EUDAMED fb781a54-6d12-48bc-8e32-31988ab6a792 61 fields · synced Jun 18, 2026
  • FDA UDI 98cb44da-5142-4f4e-9b83-4b29cf2a2679 33 fields · synced May 30, 2026